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Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip

Primary Purpose

Osteoarthritis, Arthritis

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

NSAID

tanezumab

NSAID

tanezumab

NSAID

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring monoclonal antibody, nerve growth factor (NGF), anti-NGF, tanezumab, PF-04383119, RN624, osteoarthritis (OA)

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence x-ray grade equal to, or greater than, 2.
Patients must be experiencing some benefit from their current stable dose regimen of oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either 100 mg BID or 200 mg QD) and be tolerating their NSAID regimen.
Pain level and function levels as required by the protocol at Screening and Baseline.
Willing to discontinue all non-study pain medications for osteoarthritis except rescue medication (acetaminophen) and not use prohibited pain medications throughout the duration of the study except as permitted per protocol.
Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

Pregnant women.
BMI greater than 39.
Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to sever pain that may confound assessments or self-evaluation of the pain associated with OA.
Signs and symptoms of clinically significant cardiac disease with 6 months prior to screening.
Diagnosis of TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities.
History, diagnosis, signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder.
At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 1.7 mg/dL (men) or 1.5 mg/dL (women).
Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening.
Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors.

Sites / Locations

Rheumatology Associates, P.C.
Radiant Research
Alliance Clinical Research
Shades Mountain Imaging
Rheumatology Associates of North Alabama, PC
Saadat Ansari, MD Office
Coastal Clinical Research, Inc.
Office of Vaughn H. Mancha, Jr., MD
Radiant Research - Phoenix Southeast
Dedicated Clinical Research
Eclipse Clinical Research
Midwest Internal Medicine, PLLC
Arizona Arthritis & Rheumatology Associates, P.C.
Pivotal Research Centers
Arizona Arthritis & Rheumatology Research, PLLC
Pivotal Research Centers
Elite Clinical Studies, LLC
Arizona Arthritis & Rheumatology Associates, P.C.
Cochise Clinical Research
Premiere Phamaceutical Research, LLC
Radiant Research
Arizona Research Associates
Quality of Life Medical and Research Center
Tucson Orthopaedic Institute
Little Rock Diagnostic Clinic, PA
Little Rock Family Practice Clinic
Advanced Clinical Research Institute
Orange County Clinical Trials, Inc.
Med Center
eStudySite
Med Investigations, Inc.
Triwest Research
Lakewood Orthopedic Medical & Surgical Group
Premier Clinical Research LLC.
Prohealth Partners
Peak Health Medical Group, Inc.
Synergy Clinical Research Center
eStudySite
Desert Medical Group Inc., Desert Oasis Healthcare
Advances in Medicine
Mercy Imaging Center
Northern Clinical Research
California Research Foundation
San Diego Arthritis Medical Clinic
Kaiser Permanente Medical Center
eStudySite
Trinity Clinical Trials
Apex Research Institute
St. Joseph Medical Associates
Westlake Medical Center
Colorado Springs Family Practice
Lynn Institute of the Rockies
Colorado Arthritis Center, PC
Joao MA Nascimento, MD
New England Research Associates, LLC
Rheumatology Consultants of Delaware/Delaware Arthritis
Arthritis and Rheumatic Disease Specialties
International Physicans Research
Surgery Center of Aventura
HeartCare
Clinical Research of West Florida, Inc.
Nature Coast Clinical Research
Homestead Clinical Research Group, P.A.
Covance CRU, Inc.
Robert W. Levin MD
Internal Medicine Associates
Clinical Physiology Associates, Clinical Study Center
Research Consultants Group
Palm Springs Research Institute
Jacksonville Center for Clinical Research
Florida Arthritis
Pharmax Research Clinic, Inc.
Community Research Foundation
International Research Associates, LLC
Jeffrey Alper MD Research
American Family Medicine
Renstar Medical Research
Sunshine Research Center
Arthritis Associates
Arthritis Research of Florida, Inc.
University Clinical Research
Pembroke Clinical Trials
Advent Clinical Research Center Inc
Advent Clinical Research Centers
Berma Research Group
Accord Clinical Research, LLC
Dale G. Bramlet, MD, P.L.
HeartCare Research
Kennedy-White Orthopaedic Center
Sarasota Center for Clinical Research
Lovelace Scientific Resources
The Arthritis Specialty Centre
Soutwest Florida Clinical Research Center
Stedman Clinical Trials
Tampa Medical Group, PA
Florida Medical Clinic, PA
Perimeter Institute for Clinical Reseach, Inc.
Laureate Clinical Research Group
ACCR/Internal Medicine
East-West Medical Research Institute
Institute of Arthritis Research
Idaho Arthritis & Osteoporosis Center, PC
Saltzer Medical Group PA
Rehabilitation Institute of Chicago
Rockford Orthopedic Associates
Springfield Clinic
Springfield Clinical Research Department
Deerbrook Medical Associates
American Health Network of Indiana, LLC
MediSphere Medical Research Center, LLC
Integrated Clinical Trial Services, Inc
Vince and Associates Clinical Research
Vince and Associates Clinical Research
Center for Arthritis and Osteoporosis
Pain Treatment Center of the Bluegrass
Pasadena Pharmacy
Commonwealth Biomedical Research, LLC
Multicare Specialists
Gulf Coast Research, LLC
The Bone and Joint Clinic
MD Medical Research
Beacon Clinical Research
Berkshire Rheumatology
MedVadis Research Corporation
Quest Research Institute
Rheumatology PC
Justus J Fiechtner, MD
PCM Medical Services
Medical Research Associates
The Center for Clinical Trials
Olive Branch Family Medical Center
Highland Community Hospital
Mississippi Medical Research
No. County Internal Medicine & Rheumatology
Dynamic Clinical Research, Inc.
Joan Prouty Moore
Orthopaedic & Occupational Medicine
Medex Healthcare Research, Inc.
Rheumatology and Internal Medicine Associates of West County, P.C.
A & A Pain Institute
Arthritis Consultants Inc.
Physician Research Collaboration, LLC
Westroads Medical Group
Anderson and Collins Clinical Research Inc.
Central Jersey Medical Research Center
Arthritis & Osteoporosis Associates, P.A.
Mark Fisher, MD, FACRUC
New Jersey Physicians, LLC
Rheumatology Associates of North Jersey
Arthritis & Osteoporosis Associates
Premier Research
Arthritis, Rheumatic & Back Disease Associates
The Center for Rheumatology, LLP
SPRI Bronx LLC
Arthritis and Osteoporosis Associates of Brooklyn Heights
NYU Hospital for Joint Diseases
Prem C. Chatpar, MD, LLC
Southgate Medical Group
Physicians East P. A.
Physicians East, PA
Clinical Trials of America, Inc
Piedmont Rheumatology
Peters Medical Research
Wake Internal Medicine Consultants Inc
Wake Research Associates
Crescent Medical Research
Internal Medicine Associates
Lillestol Research, LLC
Daystar Clinical Research, Inc.
New Horizons Clinical Research
Doctor's Urgent Care Offices
Sterling Research Group
Columbus Clinical Research, Inc.
Optimed Research, LTD
STAT Research, Inc.
Dayton Science Institute (DSI)
Hometown Urgent Care and Research
PHP - Center for Clinical Research
David R. Mandel, MD, Inc
Southwest Rheumatology and Research Group, LLC
Integris Family Care of Norman
LION Research
Central Sooner Research
Elise Wiesner, MD
McBride Clinic, Inc
McBride Clinic
McBride Clinic, Inc
Bone and Joint Hospital at St. Anthony
Christine Codding, MD
Health Research of Oklahoma
Mc Bride Clinic
Lynn Health Science Institute
Associated Orthopedics, Inc.
Hillcrest Clinical Research
Rheumatology Associates Inc
Aquilo Clinical Research
Bend Memorial Clinic
Bend Memorial Clinic
Blair Orthopedics Associates
Clinical Trials Research Services, LLC
Omega Medical Research
The Family Healthcare Center, PA
Columbia Arthritis Center P.A.
Southern Orthopaedic Sports Medicine
Radiant Research Inc
The Carolina Center for Rheumatology and Arthritis Care, PA
Regional Health Clinical Research
Regional Medical Clinical-Rheumatology
Arthritis Clinic
Ramesh C. Gupta, M.D.
Abilene Arthritis Center
Tekton Research, Inc.
Dr. Paul K. Pickrell (Physician's Office)
Metroplex Clinical Research Center
One Step Diagnostic
Accurate Clinical Research
Miracle Medical Center
DM Clinical Research
Gill Orthopedic Center
Robert R. King, M.D.
Southwest Rheumatology, PA
Hill Country Medical Associates
Neurology Clinic of Central Texas
Philip Blum
Pearland Primary Care Associates
Southwest Clinical Research Centers, LLC
Plano Primary Care Clinic
Advanced Family Medical Care
Alamo Clinical Research Associates
Alamo Clinical Research Consultants
Texas Arthritis Research Center, PA
Clinical Trials of Texas, Inc.
Innovative Clinical Trials
Radiant Research San Antonio
SAM Clinical Research Center
San Antonio Preventive & Diagnostic Medicine, PA
South Texas Radiology Imaging Center
The Rehab Group
Sugar Land Med-Ped, PA
Scott & White Healthcare
Martin Diagnostic Clinic
Pivotal Research Centers
Optimum Clinical Research, Inc.
Radiant Research, Inc.
Doris M. Rice, M.D., F.A.C.R.
National Clinical Research Richmond Inc.
Hypothe Test, LLC
Northwest Clinical Research Center
Tacoma Center for Arthritis Research, PS
Gundersen Clinic Ltd.
Office of Diane Wilson
MAC Research Inc.
KW Musculoskeletal Research Inc.
The Arthritis Program Research Group
SKDS Research Inc.
Dr. Saeed Shaikh
Dr. Anil Gupta
Diex Research Sherbrooke Inc.
Polyclinique St. Eustache
Centre de Recherche Musculo-Squelettique
Groupe de Recherche en Rhumatologie et Maladies Osseuses
Clinique Medicale St-Louis
Hospital Pablo Tobon Uribe
Centro Integral de Reumatologia e Inmunologia CIREI
Riesgo de Fractura S.A.
Clinica Las Americas
Reumatologya S.A.
Krishna Institute of Medical Sciences Ltd., Department of Rheumatology
St. Johns Medical College Hospital, Department of Orthopaedics
M.S. Ramaiah Memorial Hospital, Department of Orthopaedics
ChanRe Rheumatology & Immunology Center & Research
KMC Hospital, Department of Orthopaedics
Sancheti Hospital
PSG Institute of Medical Sciences and Research
CSM Medical University, Department of Rheumatology
Kyungpook National University Hospital
Inha University Hospital
Seoul National University Hospital
Hanyang University Hospital
The Catholic University of Korea, Seoul St.Mary's Hospital
URHIA(Unidad de Investigacion en Reumatologia)Hospital Civil de Guadalajara"Fray Antonio Alcalde"
Unidad de Enfermedades Reumaticas y Cronico Degenerativas S.C.
Hospital General de Culiacan, S.S., "Dr. Bernardo Gastelum".
Hospital Aranda de la Parra
Beneficencia Espanola de la Laguna
READE
UMC St. Radboud
UMC Utrecht
Cebu Orthopedic Institute
Chong Hua Hospital, Medical Arts Center
Diaz Building
Davao Doctors Hospital, Medical Tower
Davao Doctors Hospital
Rayuma Clinic, OPD , Jose Reyes Memorial Medical Center
Chinese General Hospital and Medical Center, Out Patient Department
Asian Hospital and Medical Center
State Healthcare Institution Moscow City Clinical Hospital #4
State Healthcare Institution: Moscow City Clinical Hospital #7
Institution Of Russian Academy of Medical Sciences
Saint Petersburg State Medical University named after Pavlov
Federal State Healthcare Institution Clinical Hospital #122 n.a.Sokolov
Saint-Petersburg State Healthcare Institution "City Hospital #26"
136 Panorama Medical Center
Phelang Private Hospital Research Unit
Tiervlei Trial Center
Worthwhile Clinical Trials
Josha Research
Vincent Pallotti Hospital
A. Briel
Private Practice
Randles Road Medical Center
Origin Clinical Research
Clinresco Centres (Pty) Ltd
Paarl Research Center
TREAD Research
Clinical Research Unit
Corporacio Sanitaria Parc Tauli de Sabadell, Servicio de Reumatologia
Hospital El Tomillar
Complejo Hospitalario Universitario de A Coruna
Hospital de Cruces, Servicio de Reumatologia
Clinica CIMA
Servicio de Reumatologia,Institut Ferran de Reumatologia-Clinica CIMA
Hospital Universitario La Paz, Servicio de Reumatologia
Hospital Nuestra Senora de la Esperanza, Servicio de Reumatologia
Hospital Nuestra Senora de Valme, Servicio de Reumatologia
Chernivtsi Regional Clinical Hospital
City Clinical Hospital #5
V.K. Gusak Institute of Urgent and Recovery Surgery
Kiev City Oleksandrivska Clinical Hospital
Kiev City Clinical Hospital #3
State Institution "Research Centre for Radiation Medicine AMS of Ukraine"
State Institution "Institute of Gerontology AMS of Ukraine"
Municipal institution :Zaporizhzhya Regional Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Arm Label

IV Placebo + NSAID

Tanezumab 5 mg

Tanezumab 10 mg

Tanezumab 5 mg + NSAID

Tanezumab 10 mg + NSAID

Arm Description

Oral NSAID

IV tanezumab 5 mg every 8 weeks (through Week 48)

IV tanezumab 10 mg every 8 weeks (through Week 48)

IV doses of tanezumab 5 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

IV doses of tanezumab 10 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16

Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.

Secondary Outcome Measures

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)

Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.

Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.

Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)

Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition).

Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)

Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was >=50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition).

Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30%, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported.

Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30 percent, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported.

Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.

Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.

Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF)

Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported.

Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF)

Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis of the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF)

The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status.

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF)

Number of Participants Who Had Discontinued Study Due to Lack of Efficacy

Time to Discontinuation Due to Lack of Efficacy

Time to discontinuation due to lack of efficacy was defined as the time interval from the date of study drug administration up to the date of discontinuation of participant from study due to lack of efficacy.

Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions (Q) are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Percentage of Participants Who Used Rescue Medication: Observed Data

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized.

Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF)

Amount of Rescue Medication Used

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified time intervals were summarized.

Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56

Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 64 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data

The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Plasma Trough (Pre-dose) Concentration of Tanezumab

Number of Participants With Intravenous (IV) Doses of Study Medication

Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received.

Full Information

NCT ID

NCT00809354

First Posted

December 16, 2008

Last Updated

June 2, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00809354

Brief Title

Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip

Official Title

A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY OF THE LONG-TERM ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ALONE OR IN COMBINATION WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) VERSUS NSAIDS ALONE IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Terminated

Why Stopped

See termination reason in detailed description.

Study Start Date

February 12, 2009 (Actual)

Primary Completion Date

October 28, 2010 (Actual)

Study Completion Date

January 12, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to investigate the long-term analgesic efficacy and safety of tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID) therapy.

Detailed Description

This study was terminated on 28 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Arthritis

Keywords

monoclonal antibody, nerve growth factor (NGF), anti-NGF, tanezumab, PF-04383119, RN624, osteoarthritis (OA)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2720 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IV Placebo + NSAID

Arm Type

Active Comparator

Arm Description

Oral NSAID

Arm Title

Tanezumab 5 mg

Arm Type

Experimental

Arm Description

IV tanezumab 5 mg every 8 weeks (through Week 48)

Arm Title

Tanezumab 10 mg

Arm Type

Experimental

Arm Description

IV tanezumab 10 mg every 8 weeks (through Week 48)

Arm Title

Tanezumab 5 mg + NSAID

Arm Type

Experimental

Arm Description

IV doses of tanezumab 5 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

Arm Title

Tanezumab 10 mg + NSAID

Arm Type

Experimental

Arm Description

IV doses of tanezumab 10 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

Intervention Type

Drug

Intervention Name(s)

NSAID

Intervention Description

IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

Intervention Type

Biological

Intervention Name(s)

tanezumab

Intervention Description

IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56

Intervention Type

Biological

Intervention Name(s)

tanezumab

Intervention Description

IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56

Intervention Type

Biological

Intervention Name(s)

tanezumab

Intervention Description

IV tanezumab 5 mg every 8 weeks (through Week 48)

Intervention Type

Drug

Intervention Name(s)

NSAID

Intervention Description

Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

Intervention Type

Biological

Intervention Name(s)

tanezumab

Intervention Description

IV tanezumab 10 mg every 8 weeks (through Week 48)

Intervention Type

Drug

Intervention Name(s)

NSAID

Intervention Description

Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

Primary Outcome Measure Information:

Title

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16

Description

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Time Frame

Baseline, Week 16

Title

Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16

Description

Time Frame

Baseline, Week 16

Secondary Outcome Measure Information:

Title

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)

Description

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Time Frame

Baseline, Weeks 2, 4, 8, 12, and 24

Title

Description

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Title

Description

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Time Frame

Baseline, Weeks 2, 4, 8, 12, and 24

Title

Description

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48, and 56

Title

Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)

Description

Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.

Time Frame

Baseline, Weeks 2, 4, 8, 12, and 24

Title

Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Description

Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Title

Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)

Description

Time Frame

Weeks 2, 4, 8, 12, 16, and 24

Title

Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)

Description

Time Frame

Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Title

Description

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30%, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, and 24

Title

Description

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30 percent, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported.

Time Frame

Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Title

Description

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.

Time Frame

Baseline, Week 16

Title

Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)

Description

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.

Time Frame

Baseline, Week 16

Title

Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF)

Description

Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported.

Time Frame

Weeks 2, 4, 8, 12, 16, and 24

Title

Description

Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported.

Time Frame

Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

Description

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis of the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, and 24

Title

Description

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, and 24

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Title

Description

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, and 24

Title

Description

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Title

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, and 24

Title

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF)

Description

Time Frame

Baseline, Weeks 12 and 24

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF)

Description

Time Frame

Baseline, Weeks 12, 24, 40, and 56

Title

Number of Participants Who Had Discontinued Study Due to Lack of Efficacy

Time Frame

Baseline up to Week 56

Title

Time to Discontinuation Due to Lack of Efficacy

Description

Time Frame

Baseline up to Week 56

Title

Description

Time Frame

Baseline, Week 24

Title

Description

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Time Frame

Baseline, Week 24 and 56

Title

Description

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Time Frame

Baseline, Week 24

Title

Description

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Time Frame

Baseline, Weeks 24 and 56

Title

Description

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Time Frame

Baseline, Week 24

Title

Description

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Time Frame

Baseline, Weeks 24 and 56

Title

Description

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Time Frame

Baseline, Week 24

Title

Description

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Time Frame

Baseline, Weeks 24, and 56

Title

Percentage of Participants Who Used Rescue Medication: Observed Data

Description

Time Frame

Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56

Title

Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF)

Description

Time Frame

Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56

Title

Amount of Rescue Medication Used

Description

Time Frame

Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48, and 49-56

Title

Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56

Time Frame

Baseline, Week 56

Title

Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56

Time Frame

Baseline, Week 56

Title

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

Baseline up to Week 64

Title

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Title

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56

Title

Plasma Trough (Pre-dose) Concentration of Tanezumab

Time Frame

Predose on Day 1, Weeks 16, 24, 40, and 56

Title

Number of Participants With Intravenous (IV) Doses of Study Medication

Description

Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received.

Time Frame

Baseline up to Week 48

Other Pre-specified Outcome Measures:

Title

Number of Participants With Anti-Drug Antibody (ADA) Response

Description

Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=4.32 for tanezumab were considered ADA positive.

Time Frame

Baseline, Weeks 16, 40, 24, and 56

Title

Number of Participants With Positive Urine or Serum Pregnancy Test

Description

Female participants, who reported positive in urine or serum pregnancy test were reported.

Time Frame

Baseline up to Week 56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence x-ray grade equal to, or greater than, 2. Patients must be experiencing some benefit from their current stable dose regimen of oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either 100 mg BID or 200 mg QD) and be tolerating their NSAID regimen. Pain level and function levels as required by the protocol at Screening and Baseline. Willing to discontinue all non-study pain medications for osteoarthritis except rescue medication (acetaminophen) and not use prohibited pain medications throughout the duration of the study except as permitted per protocol. Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria: Pregnant women. BMI greater than 39. Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to sever pain that may confound assessments or self-evaluation of the pain associated with OA. Signs and symptoms of clinically significant cardiac disease with 6 months prior to screening. Diagnosis of TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities. History, diagnosis, signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder. At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 1.7 mg/dL (men) or 1.5 mg/dL (women). Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening. Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Rheumatology Associates, P.C.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Radiant Research

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Alliance Clinical Research

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35215

Country

United States

Facility Name

Shades Mountain Imaging

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35216

Country

United States

Facility Name

Rheumatology Associates of North Alabama, PC

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Saadat Ansari, MD Office

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Coastal Clinical Research, Inc.

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Office of Vaughn H. Mancha, Jr., MD

City

Montgomery

State/Province

Alabama

ZIP/Postal Code

36117

Country

United States

Facility Name

Radiant Research - Phoenix Southeast

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85225

Country

United States

Facility Name

Dedicated Clinical Research

City

Goodyear

State/Province

Arizona

ZIP/Postal Code

85395

Country

United States

Facility Name

Eclipse Clinical Research

City

Green Valley

State/Province

Arizona

ZIP/Postal Code

85614

Country

United States

Facility Name

Midwest Internal Medicine, PLLC

City

Lake Havasu City

State/Province

Arizona

ZIP/Postal Code

86403

Country

United States

Facility Name

Arizona Arthritis & Rheumatology Associates, P.C.

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85202

Country

United States

Facility Name

Pivotal Research Centers

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

Arizona Arthritis & Rheumatology Research, PLLC

City

Paradise Valley

State/Province

Arizona

ZIP/Postal Code

85253

Country

United States

Facility Name

Pivotal Research Centers

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Elite Clinical Studies, LLC

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Arizona Arthritis & Rheumatology Associates, P.C.

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85037

Country

United States

Facility Name

Cochise Clinical Research

City

Sierra Vista

State/Province

Arizona

ZIP/Postal Code

85635

Country

United States

Facility Name

Premiere Phamaceutical Research, LLC

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85282

Country

United States

Facility Name

Radiant Research

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85710

Country

United States

Facility Name

Arizona Research Associates

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712-2142

Country

United States

Facility Name

Quality of Life Medical and Research Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Tucson Orthopaedic Institute

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Little Rock Diagnostic Clinic, PA

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Little Rock Family Practice Clinic

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Advanced Clinical Research Institute

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Orange County Clinical Trials, Inc.

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Med Center

City

Carmichael

State/Province

California

ZIP/Postal Code

95608

Country

United States

Facility Name

eStudySite

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

Facility Name

Med Investigations, Inc.

City

Fair Oaks

State/Province

California

ZIP/Postal Code

95628

Country

United States

Facility Name

Triwest Research

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Lakewood Orthopedic Medical & Surgical Group

City

Lakewood

State/Province

California

ZIP/Postal Code

90712

Country

United States

Facility Name

Premier Clinical Research LLC.

City

Lakewood

State/Province

California

ZIP/Postal Code

90712

Country

United States

Facility Name

Prohealth Partners

City

Long Beach

State/Province

California

ZIP/Postal Code

90808

Country

United States

Facility Name

Peak Health Medical Group, Inc.

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Synergy Clinical Research Center

City

National City

State/Province

California

ZIP/Postal Code

91950

Country

United States

Facility Name

eStudySite

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Desert Medical Group Inc., Desert Oasis Healthcare

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262

Country

United States

Facility Name

Advances in Medicine

City

Rancho Mirage

State/Province

California

ZIP/Postal Code

92270

Country

United States

Facility Name

Mercy Imaging Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95823

Country

United States

Facility Name

Northern Clinical Research

City

Sacramento

State/Province

California

ZIP/Postal Code

95831

Country

United States

Facility Name

California Research Foundation

City

San Diego

State/Province

California

ZIP/Postal Code

92103-6204

Country

United States

Facility Name

San Diego Arthritis Medical Clinic

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Kaiser Permanente Medical Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94118

Country

United States

Facility Name

eStudySite

City

San Jose

State/Province

California

ZIP/Postal Code

95124

Country

United States

Facility Name

Trinity Clinical Trials

City

Santa Ana

State/Province

California

ZIP/Postal Code

92701

Country

United States

Facility Name

Apex Research Institute

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

St. Joseph Medical Associates

City

Stockton

State/Province

California

ZIP/Postal Code

95204

Country

United States

Facility Name

Westlake Medical Center

City

Westlake Village

State/Province

California

ZIP/Postal Code

91361

Country

United States

Facility Name

Colorado Springs Family Practice

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80909

Country

United States

Facility Name

Lynn Institute of the Rockies

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80909

Country

United States

Facility Name

Colorado Arthritis Center, PC

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Joao MA Nascimento, MD

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06606

Country

United States

Facility Name

New England Research Associates, LLC

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

Facility Name

Rheumatology Consultants of Delaware/Delaware Arthritis

City

Lewes

State/Province

Delaware

ZIP/Postal Code

19958

Country

United States

Facility Name

Arthritis and Rheumatic Disease Specialties

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

International Physicans Research

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Surgery Center of Aventura

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

HeartCare

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34202

Country

United States

Facility Name

Clinical Research of West Florida, Inc.

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Nature Coast Clinical Research

City

Crystal River

State/Province

Florida

ZIP/Postal Code

34429

Country

United States

Facility Name

Homestead Clinical Research Group, P.A.

City

Cutler Bay

State/Province

Florida

ZIP/Postal Code

33189

Country

United States

Facility Name

Covance CRU, Inc.

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Robert W. Levin MD

City

Dunedin

State/Province

Florida

ZIP/Postal Code

34698

Country

United States

Facility Name

Internal Medicine Associates

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

Facility Name

Clinical Physiology Associates, Clinical Study Center

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

Research Consultants Group

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33010

Country

United States

Facility Name

Palm Springs Research Institute

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Jacksonville Center for Clinical Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Florida Arthritis

City

Lake Mary

State/Province

Florida

ZIP/Postal Code

32746

Country

United States

Facility Name

Pharmax Research Clinic, Inc.

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Community Research Foundation

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

International Research Associates, LLC

City

Miami

State/Province

Florida

ZIP/Postal Code

33183

Country

United States

Facility Name

Jeffrey Alper MD Research

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

American Family Medicine

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Renstar Medical Research

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Sunshine Research Center

City

Opa-locka

State/Province

Florida

ZIP/Postal Code

33054-3818

Country

United States

Facility Name

Arthritis Associates

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Arthritis Research of Florida, Inc.

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

University Clinical Research

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Pembroke Clinical Trials

City

Pemkbroke Pines

State/Province

Florida

ZIP/Postal Code

33028

Country

United States

Facility Name

Advent Clinical Research Center Inc

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

Facility Name

Advent Clinical Research Centers

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

Facility Name

Berma Research Group

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Accord Clinical Research, LLC

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32129

Country

United States

Facility Name

Dale G. Bramlet, MD, P.L.

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33713

Country

United States

Facility Name

HeartCare Research

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34232

Country

United States

Facility Name

Kennedy-White Orthopaedic Center

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34232

Country

United States

Facility Name

Sarasota Center for Clinical Research

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34232

Country

United States

Facility Name

Lovelace Scientific Resources

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34233

Country

United States

Facility Name

The Arthritis Specialty Centre

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34233

Country

United States

Facility Name

Soutwest Florida Clinical Research Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609-3018

Country

United States

Facility Name

Stedman Clinical Trials

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Tampa Medical Group, PA

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Florida Medical Clinic, PA

City

Zephyrhills

State/Province

Florida

ZIP/Postal Code

33542

Country

United States

Facility Name

Perimeter Institute for Clinical Reseach, Inc.

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30338

Country

United States

Facility Name

Laureate Clinical Research Group

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

ACCR/Internal Medicine

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30075

Country

United States

Facility Name

East-West Medical Research Institute

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

Institute of Arthritis Research

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Idaho Arthritis & Osteoporosis Center, PC

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642-6356

Country

United States

Facility Name

Saltzer Medical Group PA

City

Nampa

State/Province

Idaho

ZIP/Postal Code

83686

Country

United States

Facility Name

Rehabilitation Institute of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Rockford Orthopedic Associates

City

Rockford

State/Province

Illinois

ZIP/Postal Code

61107

Country

United States

Facility Name

Springfield Clinic

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62702

Country

United States

Facility Name

Springfield Clinical Research Department

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62703

Country

United States

Facility Name

Deerbrook Medical Associates

City

Vernon Hills

State/Province

Illinois

ZIP/Postal Code

60061

Country

United States

Facility Name

American Health Network of Indiana, LLC

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

MediSphere Medical Research Center, LLC

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Integrated Clinical Trial Services, Inc

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50265

Country

United States

Facility Name

Vince and Associates Clinical Research

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

Facility Name

Vince and Associates Clinical Research

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

Facility Name

Center for Arthritis and Osteoporosis

City

Elizabethtown

State/Province

Kentucky

ZIP/Postal Code

42701

Country

United States

Facility Name

Pain Treatment Center of the Bluegrass

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Pasadena Pharmacy

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Commonwealth Biomedical Research, LLC

City

Madisonville

State/Province

Kentucky

ZIP/Postal Code

42431

Country

United States

Facility Name

Multicare Specialists

City

Madisonville

State/Province

Kentucky

ZIP/Postal Code

42431

Country

United States

Facility Name

Gulf Coast Research, LLC

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

The Bone and Joint Clinic

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

MD Medical Research

City

Oxon Hill

State/Province

Maryland

ZIP/Postal Code

20745

Country

United States

Facility Name

Beacon Clinical Research

City

Brockton

State/Province

Massachusetts

ZIP/Postal Code

02301

Country

United States

Facility Name

Berkshire Rheumatology

City

Pittsfield

State/Province

Massachusetts

ZIP/Postal Code

01201

Country

United States

Facility Name

MedVadis Research Corporation

City

Watertown

State/Province

Massachusetts

ZIP/Postal Code

02472

Country

United States

Facility Name

Quest Research Institute

City

Bingham Farms

State/Province

Michigan

ZIP/Postal Code

48025

Country

United States

Facility Name

Rheumatology PC

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49009

Country

United States

Facility Name

Justus J Fiechtner, MD

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910-8595

Country

United States

Facility Name

PCM Medical Services

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48917

Country

United States

Facility Name

Medical Research Associates

City

Traverse City

State/Province

Michigan

ZIP/Postal Code

49684

Country

United States

Facility Name

The Center for Clinical Trials

City

Biloxi

State/Province

Mississippi

ZIP/Postal Code

39531

Country

United States

Facility Name

Olive Branch Family Medical Center

City

Olive Branch

State/Province

Mississippi

ZIP/Postal Code

38654

Country

United States

Facility Name

Highland Community Hospital

City

Picayune

State/Province

Mississippi

ZIP/Postal Code

39466

Country

United States

Facility Name

Mississippi Medical Research

City

Picayune

State/Province

Mississippi

ZIP/Postal Code

39466

Country

United States

Facility Name

No. County Internal Medicine & Rheumatology

City

Florissant

State/Province

Missouri

ZIP/Postal Code

63031

Country

United States

Facility Name

Dynamic Clinical Research, Inc.

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

Joan Prouty Moore

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

Orthopaedic & Occupational Medicine

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

Medex Healthcare Research, Inc.

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

Rheumatology and Internal Medicine Associates of West County, P.C.

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63131

Country

United States

Facility Name

A & A Pain Institute

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Arthritis Consultants Inc.

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Physician Research Collaboration, LLC

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Westroads Medical Group

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Anderson and Collins Clinical Research Inc.

City

Edison

State/Province

New Jersey

ZIP/Postal Code

08817

Country

United States

Facility Name

Central Jersey Medical Research Center

City

Elizabeth

State/Province

New Jersey

ZIP/Postal Code

07202

Country

United States

Facility Name

Arthritis & Osteoporosis Associates, P.A.

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

Mark Fisher, MD, FACRUC

City

Haddon Heights

State/Province

New Jersey

ZIP/Postal Code

08035

Country

United States

Facility Name

New Jersey Physicians, LLC

City

Passaic

State/Province

New Jersey

ZIP/Postal Code

07055

Country

United States

Facility Name

Rheumatology Associates of North Jersey

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

Facility Name

Arthritis & Osteoporosis Associates

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08757

Country

United States

Facility Name

Premier Research

City

Trenton

State/Province

New Jersey

ZIP/Postal Code

08611

Country

United States

Facility Name

Arthritis, Rheumatic & Back Disease Associates

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

The Center for Rheumatology, LLP

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

SPRI Bronx LLC

City

Bronx

State/Province

New York

ZIP/Postal Code

10454

Country

United States

Facility Name

Arthritis and Osteoporosis Associates of Brooklyn Heights

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201

Country

United States

Facility Name

NYU Hospital for Joint Diseases

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

Facility Name

Prem C. Chatpar, MD, LLC

City

Plainview

State/Province

New York

ZIP/Postal Code

11803

Country

United States

Facility Name

Southgate Medical Group

City

West Seneca

State/Province

New York

ZIP/Postal Code

14224

Country

United States

Facility Name

Physicians East P. A.

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Physicians East, PA

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Clinical Trials of America, Inc

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

Piedmont Rheumatology

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28602

Country

United States

Facility Name

Peters Medical Research

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Wake Internal Medicine Consultants Inc

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Wake Research Associates

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Crescent Medical Research

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Internal Medicine Associates

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Lillestol Research, LLC

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Daystar Clinical Research, Inc.

City

Akron

State/Province

Ohio

ZIP/Postal Code

44313

Country

United States

Facility Name

New Horizons Clinical Research

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Doctor's Urgent Care Offices

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45246

Country

United States

Facility Name

Sterling Research Group

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45246

Country

United States

Facility Name

Columbus Clinical Research, Inc.

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Optimed Research, LTD

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43235

Country

United States

Facility Name

STAT Research, Inc.

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45408

Country

United States

Facility Name

Dayton Science Institute (DSI)

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45415

Country

United States

Facility Name

Hometown Urgent Care and Research

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45432

Country

United States

Facility Name

PHP - Center for Clinical Research

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45439

Country

United States

Facility Name

David R. Mandel, MD, Inc

City

Mayfield

State/Province

Ohio

ZIP/Postal Code

44143

Country

United States

Facility Name

Southwest Rheumatology and Research Group, LLC

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

Integris Family Care of Norman

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73069

Country

United States

Facility Name

LION Research

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73069

Country

United States

Facility Name

Central Sooner Research

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73071

Country

United States

Facility Name

Elise Wiesner, MD

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73071

Country

United States

Facility Name

McBride Clinic, Inc

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73072

Country

United States

Facility Name

McBride Clinic

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73072

Country

United States

Facility Name

McBride Clinic, Inc

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73013

Country

United States

Facility Name

Bone and Joint Hospital at St. Anthony

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Christine Codding, MD

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Health Research of Oklahoma

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Mc Bride Clinic

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Lynn Health Science Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Associated Orthopedics, Inc.

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73119

Country

United States

Facility Name

Hillcrest Clinical Research

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73119

Country

United States

Facility Name

Rheumatology Associates Inc

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Aquilo Clinical Research

City

Yukon

State/Province

Oklahoma

ZIP/Postal Code

73099

Country

United States

Facility Name

Bend Memorial Clinic

City

Bend

State/Province

Oregon

ZIP/Postal Code

97701

Country

United States

Facility Name

Bend Memorial Clinic

City

Bend

State/Province

Oregon

ZIP/Postal Code

97702

Country

United States

Facility Name

Blair Orthopedics Associates

City

Altoona

State/Province

Pennsylvania

ZIP/Postal Code

16602

Country

United States

Facility Name

Clinical Trials Research Services, LLC

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15206

Country

United States

Facility Name

Omega Medical Research

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

Facility Name

The Family Healthcare Center, PA

City

Clinton

State/Province

South Carolina

ZIP/Postal Code

29325

Country

United States

Facility Name

Columbia Arthritis Center P.A.

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

Southern Orthopaedic Sports Medicine

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

Radiant Research Inc

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

The Carolina Center for Rheumatology and Arthritis Care, PA

City

Rock Hill

State/Province

South Carolina

ZIP/Postal Code

29732

Country

United States

Facility Name

Regional Health Clinical Research

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Regional Medical Clinical-Rheumatology

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Arthritis Clinic

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Ramesh C. Gupta, M.D.

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Abilene Arthritis Center

City

Abilene

State/Province

Texas

ZIP/Postal Code

79601

Country

United States

Facility Name

Tekton Research, Inc.

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

Dr. Paul K. Pickrell (Physician's Office)

City

Austin

State/Province

Texas

ZIP/Postal Code

78746

Country

United States

Facility Name

Metroplex Clinical Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

One Step Diagnostic

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Accurate Clinical Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

Facility Name

Miracle Medical Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77055

Country

United States

Facility Name

DM Clinical Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77070

Country

United States

Facility Name

Gill Orthopedic Center

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

Robert R. King, M.D.

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

Southwest Rheumatology, PA

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

Hill Country Medical Associates

City

New Braunfels

State/Province

Texas

ZIP/Postal Code

78130

Country

United States

Facility Name

Neurology Clinic of Central Texas

City

New Braunfels

State/Province

Texas

ZIP/Postal Code

78130

Country

United States

Facility Name

Philip Blum

City

Pasadena

State/Province

Texas

ZIP/Postal Code

77504

Country

United States

Facility Name

Pearland Primary Care Associates

City

Pearland

State/Province

Texas

ZIP/Postal Code

77584

Country

United States

Facility Name

Southwest Clinical Research Centers, LLC

City

Pearland

State/Province

Texas

ZIP/Postal Code

77584

Country

United States

Facility Name

Plano Primary Care Clinic

City

Plano

State/Province

Texas

ZIP/Postal Code

75075

Country

United States

Facility Name

Advanced Family Medical Care

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Alamo Clinical Research Associates

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78212

Country

United States

Facility Name

Alamo Clinical Research Consultants

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78212

Country

United States

Facility Name

Texas Arthritis Research Center, PA

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

Clinical Trials of Texas, Inc.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Innovative Clinical Trials

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Radiant Research San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

SAM Clinical Research Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

San Antonio Preventive & Diagnostic Medicine, PA

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

South Texas Radiology Imaging Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

The Rehab Group

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Sugar Land Med-Ped, PA

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

Scott & White Healthcare

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Facility Name

Martin Diagnostic Clinic

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

Pivotal Research Centers

City

Midvale

State/Province

Utah

ZIP/Postal Code

84047

Country

United States

Facility Name

Optimum Clinical Research, Inc.

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102

Country

United States

Facility Name

Radiant Research, Inc.

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Doris M. Rice, M.D., F.A.C.R.

City

Portsmouth

State/Province

Virginia

ZIP/Postal Code

23701

Country

United States

Facility Name

National Clinical Research Richmond Inc.

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Hypothe Test, LLC

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24018

Country

United States

Facility Name

Northwest Clinical Research Center

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98007

Country

United States

Facility Name

Tacoma Center for Arthritis Research, PS

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405-2308

Country

United States

Facility Name

Gundersen Clinic Ltd.

City

Onalaska

State/Province

Wisconsin

ZIP/Postal Code

54650

Country

United States

Facility Name

Office of Diane Wilson

City

Lunenburg

State/Province

Nova Scotia

ZIP/Postal Code

B0J 2C0

Country

Canada

Facility Name

MAC Research Inc.

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 2B6

Country

Canada

Facility Name

KW Musculoskeletal Research Inc.

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2M 5N6

Country

Canada

Facility Name

The Arthritis Program Research Group

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 3R7

Country

Canada

Facility Name

SKDS Research Inc.

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 5G8

Country

Canada

Facility Name

Dr. Saeed Shaikh

City

St. Catharines

State/Province

Ontario

ZIP/Postal Code

L2N 7E4

Country

Canada

Facility Name

Dr. Anil Gupta

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9V 4B4

Country

Canada

Facility Name

Diex Research Sherbrooke Inc.

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 1Z1

Country

Canada

Facility Name

Polyclinique St. Eustache

City

St. Eustache

State/Province

Quebec

ZIP/Postal Code

J7P 4J2

Country

Canada

Facility Name

Centre de Recherche Musculo-Squelettique

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

Groupe de Recherche en Rhumatologie et Maladies Osseuses

City

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

Clinique Medicale St-Louis

City

Quebec

ZIP/Postal Code

G1W 4R4

Country

Canada

Facility Name

Hospital Pablo Tobon Uribe

City

Medellin

State/Province

Antioquia

Country

Colombia

Facility Name

Centro Integral de Reumatologia e Inmunologia CIREI

City

Bogota

State/Province

Cundinamarca

Country

Colombia

Facility Name

Riesgo de Fractura S.A.

City

Bogota-Cundinamarca

Country

Colombia

Facility Name

Clinica Las Americas

City

Medellin

Country

Colombia

Facility Name

Reumatologya S.A.

City

Medellin

Country

Colombia

Facility Name

Krishna Institute of Medical Sciences Ltd., Department of Rheumatology

City

Secunderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500003

Country

India

Facility Name

St. Johns Medical College Hospital, Department of Orthopaedics

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560034

Country

India

Facility Name

M.S. Ramaiah Memorial Hospital, Department of Orthopaedics

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560054

Country

India

Facility Name

ChanRe Rheumatology & Immunology Center & Research

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560079

Country

India

Facility Name

KMC Hospital, Department of Orthopaedics

City

Mangalore

State/Province

Karnataka

ZIP/Postal Code

575 001

Country

India

Facility Name

Sancheti Hospital

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411 005

Country

India

Facility Name

PSG Institute of Medical Sciences and Research

City

Coimbatore

State/Province

Tamilnadu

ZIP/Postal Code

641004

Country

India

Facility Name

CSM Medical University, Department of Rheumatology

City

Lucknow

State/Province

ZIP/Postal Code

226018

Country

India

Facility Name

Kyungpook National University Hospital

City

Daegu

ZIP/Postal Code

700-721

Country

Korea, Republic of

Facility Name

Inha University Hospital

City

Incheon

ZIP/Postal Code

400-711

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Hanyang University Hospital

City

Seoul

ZIP/Postal Code

133-792

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, Seoul St.Mary's Hospital

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

URHIA(Unidad de Investigacion en Reumatologia)Hospital Civil de Guadalajara"Fray Antonio Alcalde"

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

CP 44280

Country

Mexico

Facility Name

Unidad de Enfermedades Reumaticas y Cronico Degenerativas S.C.

City

Coahuila

ZIP/Postal Code

27000

Country

Mexico

Facility Name

Hospital General de Culiacan, S.S., "Dr. Bernardo Gastelum".

City

Culiacan Sinaloa

ZIP/Postal Code

CP 80230

Country

Mexico

Facility Name

Hospital Aranda de la Parra

City

Leon Gto

ZIP/Postal Code

C.P. 37000

Country

Mexico

Facility Name

Beneficencia Espanola de la Laguna

City

Torreon Coahuila

ZIP/Postal Code

CP 27000

Country

Mexico

Facility Name

READE

City

Amsterdam

ZIP/Postal Code

1056 AB

Country

Netherlands

Facility Name

UMC St. Radboud

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

UMC Utrecht

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Cebu Orthopedic Institute

City

Cebu City

ZIP/Postal Code

6000

Country

Philippines

Facility Name

Chong Hua Hospital, Medical Arts Center

City

Cebu City

ZIP/Postal Code

6000

Country

Philippines

Facility Name

Diaz Building

City

Cebu City

ZIP/Postal Code

6000

Country

Philippines

Facility Name

Davao Doctors Hospital, Medical Tower

City

Davao City

ZIP/Postal Code

8000

Country

Philippines

Facility Name

Davao Doctors Hospital

City

Davao City

ZIP/Postal Code

8000

Country

Philippines

Facility Name

Rayuma Clinic, OPD , Jose Reyes Memorial Medical Center

City

Manila

ZIP/Postal Code

1003

Country

Philippines

Facility Name

Chinese General Hospital and Medical Center, Out Patient Department

City

Manila

Country

Philippines

Facility Name

Asian Hospital and Medical Center

City

Muntinlupa

ZIP/Postal Code

1780

Country

Philippines

Facility Name

State Healthcare Institution Moscow City Clinical Hospital #4

City

Moscow

ZIP/Postal Code

115093

Country

Russian Federation

Facility Name

State Healthcare Institution: Moscow City Clinical Hospital #7

City

Moscow

ZIP/Postal Code

115446

Country

Russian Federation

Facility Name

Institution Of Russian Academy of Medical Sciences

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Saint Petersburg State Medical University named after Pavlov

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Federal State Healthcare Institution Clinical Hospital #122 n.a.Sokolov

City

Saint-Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Saint-Petersburg State Healthcare Institution "City Hospital #26"

City

Saint-Petersburg

ZIP/Postal Code

196247

Country

Russian Federation

Facility Name

136 Panorama Medical Center

City

Panorama

State/Province

Cape Town

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Phelang Private Hospital Research Unit

City

Mamelodi East

State/Province

Pretoria

ZIP/Postal Code

0122

Country

South Africa

Facility Name

Tiervlei Trial Center

City

Bellville

Country

South Africa

Facility Name

Worthwhile Clinical Trials

City

Benoni

ZIP/Postal Code

1500

Country

South Africa

Facility Name

Josha Research

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Vincent Pallotti Hospital

City

Cape Town

ZIP/Postal Code

7405

Country

South Africa

Facility Name

A. Briel

City

Durbanville

ZIP/Postal Code

7550

Country

South Africa

Facility Name

Private Practice

City

Durban

ZIP/Postal Code

4091

Country

South Africa

Facility Name

Randles Road Medical Center

City

Durban

ZIP/Postal Code

4091

Country

South Africa

Facility Name

Origin Clinical Research

City

Johannesburg

ZIP/Postal Code

2060

Country

South Africa

Facility Name

Clinresco Centres (Pty) Ltd

City

Kempton Park

ZIP/Postal Code

1619

Country

South Africa

Facility Name

Paarl Research Center

City

Paarl

ZIP/Postal Code

7646

Country

South Africa

Facility Name

TREAD Research

City

Parrowvalley

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Clinical Research Unit

City

Pretoria

ZIP/Postal Code

0083

Country

South Africa

Facility Name

Corporacio Sanitaria Parc Tauli de Sabadell, Servicio de Reumatologia

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Hospital El Tomillar

City

Dos Hermanas

State/Province

Sevilla

ZIP/Postal Code

41700

Country

Spain

Facility Name

Complejo Hospitalario Universitario de A Coruna

City

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital de Cruces, Servicio de Reumatologia

City

Barakaldo (Vizcaya)

ZIP/Postal Code

48903

Country

Spain

Facility Name

Clinica CIMA

City

Barcelona

ZIP/Postal Code

08034

Country

Spain

Facility Name

Servicio de Reumatologia,Institut Ferran de Reumatologia-Clinica CIMA

City

Barcelona

ZIP/Postal Code

08034

Country

Spain

Facility Name

Hospital Universitario La Paz, Servicio de Reumatologia

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hospital Nuestra Senora de la Esperanza, Servicio de Reumatologia

City

Santiago De Compostela, A Coruna

ZIP/Postal Code

15705

Country

Spain

Facility Name

Hospital Nuestra Senora de Valme, Servicio de Reumatologia

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

Chernivtsi Regional Clinical Hospital

City

Chernivtsi

ZIP/Postal Code

58002

Country

Ukraine

Facility Name

City Clinical Hospital #5

City

Donetsk

ZIP/Postal Code

83000

Country

Ukraine

Facility Name

V.K. Gusak Institute of Urgent and Recovery Surgery

City

Donetsk

ZIP/Postal Code

83045

Country

Ukraine

Facility Name

Kiev City Oleksandrivska Clinical Hospital

City

Kiev

ZIP/Postal Code

01601

Country

Ukraine

Facility Name

Kiev City Clinical Hospital #3

City

Kiev

ZIP/Postal Code

02125

Country

Ukraine

Facility Name

State Institution "Research Centre for Radiation Medicine AMS of Ukraine"

City

Kiev

ZIP/Postal Code

03115

Country

Ukraine

Facility Name

State Institution "Institute of Gerontology AMS of Ukraine"

City

Kiev

ZIP/Postal Code

04114

Country

Ukraine

Facility Name

Municipal institution :Zaporizhzhya Regional Clinical Hospital

City

Zaporizhzhya

ZIP/Postal Code

69600

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

30936738

Citation

Tive L, Bello AE, Radin D, Schnitzer TJ, Nguyen H, Brown MT, West CR. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip. J Pain Res. 2019 Mar 19;12:975-995. doi: 10.2147/JPR.S191297. eCollection 2019. Erratum In: J Pain Res. 2020 Sep 14;13:2267-2268.

Results Reference

derived

PubMed Identifier

26554876

Citation

Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.

Results Reference

derived

PubMed Identifier

24625625

Citation

Schnitzer TJ, Ekman EF, Spierings EL, Greenberg HS, Smith MD, Brown MT, West CR, Verburg KM. Efficacy and safety of tanezumab monotherapy or combined with non-steroidal anti-inflammatory drugs in the treatment of knee or hip osteoarthritis pain. Ann Rheum Dis. 2015 Jun;74(6):1202-11. doi: 10.1136/annrheumdis-2013-204905. Epub 2014 Mar 13.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091025&StudyName=Long-Term%20Analgesic%20Efficacy%20And%20Safety%20Of%20Tanezumab%20Alone%20Or%20In%20Combination%20With%20Non-Steroidal%20Anti-Inflammatory%20Drugs%20%28NSAIDs%29%20Versus%20

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip

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