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Tanezumab In Osteoarthritis Of The Hip Or Knee

Primary Purpose

Osteoarthritis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tanezumab 10 mg
tanezumab 5 mg
oxycodone
placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring monoclonal antibody, RN624, PF-04383119, nerve growth factor, OA, pain, arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • osteoarthritis of the knee or hip according to Kellgren-Lawrence x-ray grade of 2

Exclusion Criteria:

  • pregnancy or intent to become pregnant
  • BMI greater than 39
  • other severe pain, significant cardiac, neurological or psychiatric disease

Sites / Locations

  • Achieve Clinical Research
  • Alabama Orthopaedic Clinics, PC
  • Horizon Research Group, Inc.
  • Arizona Research Center, Inc.
  • Osteoporosis Medical Center
  • Med Frontier Clinical Research
  • Providence Clinical Research
  • Valley Research
  • Apex Research Institute
  • Medvin Clinical Research
  • Advanced Radiology
  • Stamford Therapeutics Consortium
  • Clinical Research of South Florida
  • Homestead Clinical Research Group, P.A.
  • Riverside Clinical Research
  • Florida Clinical Research Center, LLC
  • Adult Medicine Specialists
  • Genesis Research International
  • Community Research Foundation, Inc.
  • Compass Research, LLC
  • Advent Clinical Research Centers, Inc.
  • Dale G. Bramlet, MD
  • Sarasota Center For Clinical Research
  • Palm Beach Research Center
  • Laureate Clinical Research Group
  • Drug Studies America Inc.
  • North Georgia Clinical Research
  • North Goergia Internal Medicine
  • Americana Orthopedics
  • Sonora Clinical Research, LLC.
  • Northwest Indiana Center for Clinical Research
  • Commonwealth Biomedical Research
  • Mid-Atlantic Medical Research
  • Miray Medical Center
  • MedVadis Research Corporation
  • Clinical Pharmacology Study Group
  • Great Lakes Research Group, Incorporated
  • The Center for Clinical Trials
  • Mercy Health Research
  • Midwest Minor Medical
  • Quality Clinical Research, Inc.
  • Midwest Minor Medical
  • Midwest Minor Medical
  • Diagnostic Center of Medicine
  • Office of Matthew Barton, MD
  • Comprehensive Clinical Research
  • Office of Andrew J. Porges, MD PC
  • MediSpect, LLC
  • Crescent Medical Research
  • Hilltop Medical Research Center
  • Columbus Clinical Research
  • Health Research of Oklahoma
  • Brandywine Clinical Research
  • Piedmont Arthritis Clinic, PA
  • Health Concepts
  • TriCities Medical Research
  • Appalachian Medical Research Inc.
  • ClinRx Research, LLC
  • Tekton Research, Inc
  • One Step Diagnostic (X-Ray Facility)
  • Pioneer Research Solutions
  • Leander Healthcare Center
  • ClinRx Research
  • Oakwell Clinical research, LLC
  • Grayline Clinical Drug Trials
  • Northwest Clinical Research Center
  • LKH/Universitatsklinikum Graz
  • Nuhr Zentrum
  • ClinPharm International GmbH
  • Synexus ClinPharm GmbH
  • Rheuma Zentrum Favoriten
  • CCBR A/S
  • CCBR A/S
  • Frederiksberg Hospital Parker Institute
  • CCBR A/S
  • Charité Universitätsmedizin Berlin
  • Klinische Forschung Berlin-Buch GmbH
  • Viereck-Apotheke
  • Charité Campus Virchow-Klinikum Apotheke
  • ClinPharm International GmbH
  • Herz Apotheke
  • Synexus ClinPharm GmbH
  • Synexus ClinPharm GmbH / Frankfurt/M
  • Schiller-Apotheke
  • Schmerz und Palliativ-Zentrum Goppingen
  • Falken Apotheke Hoheluft
  • Klinische Forschung Hamburg GmbH
  • Klinische Forschung Hannover-Mitte GmbH
  • Löwen Apotheke
  • Synexus ClinPharm GmbH
  • Arkana Apotheke OHG
  • Synexus ClinPharm GmbH Pruefzentrum Magdeburg
  • Apotheke im MSZ
  • Schwanen Apotheke am Markt
  • Klinische Forschung Schwerin GmbH
  • Sonnenapotheke
  • Nzoz Centrum Medyczne
  • Szpital Specjalistyczny im. J. Dietla
  • NZOZ REUMED Sp.zo.o.
  • Medyczne Centrum Hetmanska
  • NZOZ "Nasz Lekarz"
  • Centrum Medyczne OSTEOMED NZOZ
  • Hospital Nuestra Senora de la Esperanza
  • Complejo Hospitalario Universitario de A Coruna
  • Hospital Regional Universitario Carlos Haya (Hospital Civil)
  • Hospital Regional Universitario Carlos Haya (Hospital Civil)
  • Hospital Universitario Virgen Macarena
  • Me3plus AB
  • Me3plus AB
  • Avdelningen for klinisk provning, Sahlgrenska Universitetssjukhuset
  • Center for Clinical Studies
  • Bragee Medect AB

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis (OA) in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: Modified Intent-to-Treat (mITT) Population
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Secondary Outcome Measures

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: mITT Population
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population
The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on an NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population
The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on an NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population
PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 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 score indicated severe condition.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population
PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 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 score indicated severe condition.
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: ITT Population
OMERACT-OARSI response: greater than or equal to (>=) 50 percent (%) improvement from baseline and absolute change from baseline of >=2 units at Week of interest in WOMAC pain or physical function subscales, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: mITT Population
OMERACT-OARSI response: >=50 percent (%) improvement from baseline and absolute change from baseline of >=2 units at Week of interest in WOMAC pain or physical function subscales, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 8 are reported.
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: ITT Population
PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 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 score indicated severe condition.
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 12 and 16: mITT Population
PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 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 score indicated severe condition.
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population
Participants assessed daily average pain in the index joint (knee/hip) during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Higher score indicated greater pain. The baseline mean was calculated using the daily pain scores in the index joint (knee/hip) over the 3 days in the initial pain assessment period and the weekly mean was calculated using the daily pain scores in the index joint (knee/hip) within each assessment week.
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population
Participants assessed daily average pain in the index joint (knee/hip) during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Higher score indicated greater pain. The baseline mean was calculated using the daily pain scores in the index joint (knee/hip) over the 3 days in the initial pain assessment period and the weekly mean was calculated using the daily pain scores in the index joint (knee/hip) within each assessment week.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population
The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10; with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in moving the index joint (knee/hip).
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population
The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10; with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in moving the index joint (knee/hip).
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: ITT Population
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with OA of the index knee or index hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: mITT Population
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with OA of the index knee or index hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response.
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: ITT Population
Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: mITT Population
Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: ITT Population
Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: mITT Population
Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population
SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100 = highest level of functioning).
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population
SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100 = highest level of functioning).
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: ITT Population
SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: mITT Population
SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement.
Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: ITT Population
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no problems (level 1), some problems (level 2), and extreme problems (level 3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: mITT Population
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no problems (level 1), some problems (level 2), and extreme problems (level 3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions/domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no dysfunction (level 1), moderate/some dysfunction (level 2), and extreme dysfunction (level 3). Change from baseline at Week 12 is defined as: Improved (positive change), No change, and Worsened (negative change). Number of participants with response is reported.
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions/domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no dysfunction (level 1), moderate/some dysfunction (level 2), and extreme dysfunction (level 3). Change from baseline at Week 12 is defined as: Improved (positive change), No change, and Worsened (negative change). Number of participants with response is reported.
Number of Participants Who Discontinued From Study Due to Lack of Efficacy
Time to Discontinuation From Study Due to Lack of Efficacy
Number of Participants With Rescue Medication (RM) Usage
In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication.
Number of Days With Rescue Medication (RM) Usage
In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication. Results are shown in number of days of rescue medication usage per week.
Amount of Rescue Medication Used
In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication. Results are presented as total dose of acetaminophen (in mg) per week.
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18
NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness are 24 items and scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes and sensation are 13 items and scored 0 = normal, 1= decreased, or 2 = absent. Total NIS score is the sum of the left and right limb scores. Total possible NIS score range 0 to 244, higher score=greater impairment.
Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA)
Human serum samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Only participants receiving tanezumab were to be analyzed for this measure. A participant may be represented in more than 1 category.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity
Pre-specified opioid-related adverse events: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty urinating, confusion and vomiting. Number of participants who experienced any of the pre-specified opioid-related adverse event are reported. Pre-specified opioid-related adverse events were assessed according to severity: mild (did not interfere with participant's usual function); moderate (interfered to some extent with participant's usual function); and severe (interfered significantly with participant's usual function).
Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity
Adverse event of abnormal peripheral sensation: allodynia, burning sensation, decreased vibratory sense, dysaesthesia, hyperaesthesia, hyperpathia, hypoaesthesia, neuralgia, neuritis, neuropathy peripheral, pallanesthesia, paraesthesia, paraesthesia oral, peripheral sensory neuropathy, polyneuropathy, sensory disturbance, sensory loss and thermohypoaesthesia. Adverse event of abnormal peripheral sensation was assessed according to severity: mild (did not interfere with participant's usual function); moderate (interfered to some extent with participant's usual function); and severe (interfered significantly with participant's usual function).
Tanezumab Plasma Concentration
Plasma concentration of tanezumab was measured using a validated, sensitive and specific enzyme-linked immunosorbent assay (ELISA). Only participants receiving tanezumab were to be analyzed for this measure.
Total Nerve Growth Factor (NGF) Serum Concentration
Serum samples were analyzed for determining total NGF concentration. Total NGF was analyzed using a validated, sensitive, and specific immune-affinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method.

Full Information

First Posted
September 25, 2009
Last Updated
April 20, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00985621
Brief Title
Tanezumab In Osteoarthritis Of The Hip Or Knee
Official Title
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO AND OXYCODONE CONTROLLED MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
October 30, 2009 (Actual)
Primary Completion Date
December 13, 2010 (Actual)
Study Completion Date
February 4, 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 the study is to test the efficacy and safety of 2 doses of tanezumab compared to oxycodone CR and placebo in patients with osteoarthritis
Detailed Description
This study was terminated on 13 Dec 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
Keywords
monoclonal antibody, RN624, PF-04383119, nerve growth factor, OA, pain, arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
614 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
tanezumab 10 mg
Intervention Description
tanezumab 10 mg one dose at weeks 0 and 8
Intervention Type
Biological
Intervention Name(s)
tanezumab 5 mg
Intervention Description
tanezumab 5 mg one dose at weeks 0 and 8
Intervention Type
Drug
Intervention Name(s)
oxycodone
Intervention Description
oxycodone CR, 10-40 mg q12h
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population
Description
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis (OA) in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Time Frame
Baseline, Week 8
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: Modified Intent-to-Treat (mITT) Population
Description
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population
Description
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Time Frame
Baseline, Weeks 2, 4, 12, and 16
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: mITT Population
Description
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Time Frame
Baseline, Weeks 2, 4, 12, and 16
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population
Description
The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on an NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Time Frame
Baseline, Week 2, 4, 8, 12, and 16
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population
Description
The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on an NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse 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 16
Title
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population
Description
PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 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 score indicated severe condition.
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 16
Title
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population
Description
PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 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 score indicated severe condition.
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 16
Title
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: ITT Population
Description
OMERACT-OARSI response: greater than or equal to (>=) 50 percent (%) improvement from baseline and absolute change from baseline of >=2 units at Week of interest in WOMAC pain or physical function subscales, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).
Time Frame
Weeks 2, 4, 8, 12, and 16
Title
Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: mITT Population
Description
OMERACT-OARSI response: >=50 percent (%) improvement from baseline and absolute change from baseline of >=2 units at Week of interest in WOMAC pain or physical function subscales, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).
Time Frame
Weeks 2, 4, 8, 12, and 16
Title
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population
Description
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Time Frame
Weeks 2, 4, 8, 12, and 16
Title
Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population
Description
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Time Frame
Weeks 2, 4, 8, 12, and 16
Title
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population
Description
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 8 are reported.
Time Frame
Week 8
Title
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population
Description
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Time Frame
Week 8
Title
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: ITT Population
Description
PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 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 score indicated severe condition.
Time Frame
Weeks 2, 4, 8, 12, and 16
Title
Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 12 and 16: mITT Population
Description
PGA: Participants answered the following question: "Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 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 score indicated severe condition.
Time Frame
Weeks 2, 4, 8, 12, and 16
Title
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population
Description
Participants assessed daily average pain in the index joint (knee/hip) during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Higher score indicated greater pain. The baseline mean was calculated using the daily pain scores in the index joint (knee/hip) over the 3 days in the initial pain assessment period and the weekly mean was calculated using the daily pain scores in the index joint (knee/hip) within each assessment week.
Time Frame
Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16
Title
Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population
Description
Participants assessed daily average pain in the index joint (knee/hip) during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Higher score indicated greater pain. The baseline mean was calculated using the daily pain scores in the index joint (knee/hip) over the 3 days in the initial pain assessment period and the weekly mean was calculated using the daily pain scores in the index joint (knee/hip) within each assessment week.
Time Frame
Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population
Description
The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10; with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in moving the index joint (knee/hip).
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 16
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population
Description
The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10; with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in moving the index joint (knee/hip).
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 16
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: ITT Population
Description
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with OA of the index knee or index hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response.
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 16
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: mITT Population
Description
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with OA of the index knee or index hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response.
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 16
Title
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: ITT Population
Description
Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 16
Title
Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: mITT Population
Description
Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 16
Title
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: ITT Population
Description
Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 16
Title
Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: mITT Population
Description
Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 16
Title
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population
Description
SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100 = highest level of functioning).
Time Frame
Baseline, Week 12
Title
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population
Description
SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100 = highest level of functioning).
Time Frame
Baseline, Week 12
Title
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: ITT Population
Description
SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement.
Time Frame
Baseline, Week 12
Title
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: mITT Population
Description
SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: ITT Population
Description
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no problems (level 1), some problems (level 2), and extreme problems (level 3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: mITT Population
Description
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no problems (level 1), some problems (level 2), and extreme problems (level 3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame
Baseline, Week 12
Title
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population
Description
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions/domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no dysfunction (level 1), moderate/some dysfunction (level 2), and extreme dysfunction (level 3). Change from baseline at Week 12 is defined as: Improved (positive change), No change, and Worsened (negative change). Number of participants with response is reported.
Time Frame
Baseline, Week 12
Title
Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population
Description
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions/domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no dysfunction (level 1), moderate/some dysfunction (level 2), and extreme dysfunction (level 3). Change from baseline at Week 12 is defined as: Improved (positive change), No change, and Worsened (negative change). Number of participants with response is reported.
Time Frame
Baseline, Week 12
Title
Number of Participants Who Discontinued From Study Due to Lack of Efficacy
Time Frame
Baseline up to Week 24
Title
Time to Discontinuation From Study Due to Lack of Efficacy
Time Frame
Baseline up to Week 24
Title
Number of Participants With Rescue Medication (RM) Usage
Description
In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication.
Time Frame
Weeks 2, 4, 8, 12, and 16
Title
Number of Days With Rescue Medication (RM) Usage
Description
In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication. Results are shown in number of days of rescue medication usage per week.
Time Frame
Weeks 2, 4, 8, 12, and 16
Title
Amount of Rescue Medication Used
Description
In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication. Results are presented as total dose of acetaminophen (in mg) per week.
Time Frame
Weeks 2, 4, 8, 12, and 16
Title
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18
Description
NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness are 24 items and scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes and sensation are 13 items and scored 0 = normal, 1= decreased, or 2 = absent. Total NIS score is the sum of the left and right limb scores. Total possible NIS score range 0 to 244, higher score=greater impairment.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, and 18
Title
Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA)
Description
Human serum samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Only participants receiving tanezumab were to be analyzed for this measure. A participant may be represented in more than 1 category.
Time Frame
Baseline, Week 8 and 18
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Time Frame
Baseline up to 112 days after last intravenous dose
Title
Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity
Description
Pre-specified opioid-related adverse events: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty urinating, confusion and vomiting. Number of participants who experienced any of the pre-specified opioid-related adverse event are reported. Pre-specified opioid-related adverse events were assessed according to severity: mild (did not interfere with participant's usual function); moderate (interfered to some extent with participant's usual function); and severe (interfered significantly with participant's usual function).
Time Frame
Baseline up to 112 days after last intravenous dose
Title
Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity
Description
Adverse event of abnormal peripheral sensation: allodynia, burning sensation, decreased vibratory sense, dysaesthesia, hyperaesthesia, hyperpathia, hypoaesthesia, neuralgia, neuritis, neuropathy peripheral, pallanesthesia, paraesthesia, paraesthesia oral, peripheral sensory neuropathy, polyneuropathy, sensory disturbance, sensory loss and thermohypoaesthesia. Adverse event of abnormal peripheral sensation was assessed according to severity: mild (did not interfere with participant's usual function); moderate (interfered to some extent with participant's usual function); and severe (interfered significantly with participant's usual function).
Time Frame
Baseline up to 112 days after last intravenous dose
Title
Tanezumab Plasma Concentration
Description
Plasma concentration of tanezumab was measured using a validated, sensitive and specific enzyme-linked immunosorbent assay (ELISA). Only participants receiving tanezumab were to be analyzed for this measure.
Time Frame
Predose, 1 hour post-dose on Day 1, Week 8; Week 18
Title
Total Nerve Growth Factor (NGF) Serum Concentration
Description
Serum samples were analyzed for determining total NGF concentration. Total NGF was analyzed using a validated, sensitive, and specific immune-affinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method.
Time Frame
Predose, 1 hour post-dose on Day 1, Week 8; Predose: Week 18
Other Pre-specified Outcome Measures:
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
Day 1 up to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: osteoarthritis of the knee or hip according to Kellgren-Lawrence x-ray grade of 2 Exclusion Criteria: pregnancy or intent to become pregnant BMI greater than 39 other severe pain, significant cardiac, neurological or psychiatric disease
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
Achieve Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Alabama Orthopaedic Clinics, PC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Horizon Research Group, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Arizona Research Center, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Osteoporosis Medical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Med Frontier Clinical Research
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Valley Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Apex Research Institute
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Medvin Clinical Research
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
Facility Name
Advanced Radiology
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
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
Riverside Clinical Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Fruitland Park
State/Province
Florida
ZIP/Postal Code
34731
Country
United States
Facility Name
Adult Medicine Specialists
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Genesis Research International
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Community Research Foundation, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Advent Clinical Research Centers, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Dale G. Bramlet, MD
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
Facility Name
Sarasota Center For Clinical Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Laureate Clinical Research Group
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Drug Studies America Inc.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
North Goergia Internal Medicine
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Americana Orthopedics
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Sonora Clinical Research, LLC.
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Northwest Indiana Center for Clinical Research
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Commonwealth Biomedical Research
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Mid-Atlantic Medical Research
City
Hollywood
State/Province
Maryland
ZIP/Postal Code
20636
Country
United States
Facility Name
Miray Medical Center
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
MedVadis Research Corporation
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472-3930
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Great Lakes Research Group, Incorporated
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
The Center for Clinical Trials
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Mercy Health Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Midwest Minor Medical
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Quality Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Midwest Minor Medical
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68127
Country
United States
Facility Name
Midwest Minor Medical
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Diagnostic Center of Medicine
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Office of Matthew Barton, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Office of Andrew J. Porges, MD PC
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
MediSpect, LLC
City
Boone
State/Province
North Carolina
ZIP/Postal Code
28607
Country
United States
Facility Name
Crescent Medical Research
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Hilltop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Columbus Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Health Research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Brandywine Clinical Research
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335-2620
Country
United States
Facility Name
Piedmont Arthritis Clinic, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601-3973
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
TriCities Medical Research
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Appalachian Medical Research Inc.
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604-1417
Country
United States
Facility Name
ClinRx Research, LLC
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Tekton Research, Inc
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78628
Country
United States
Facility Name
One Step Diagnostic (X-Ray Facility)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pioneer Research Solutions
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Leander Healthcare Center
City
Leander
State/Province
Texas
ZIP/Postal Code
78641
Country
United States
Facility Name
ClinRx Research
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Oakwell Clinical research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
LKH/Universitatsklinikum Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Nuhr Zentrum
City
Senftenberg
ZIP/Postal Code
A-3541
Country
Austria
Facility Name
ClinPharm International GmbH
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Synexus ClinPharm GmbH
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Rheuma Zentrum Favoriten
City
Wien
ZIP/Postal Code
A-1100
Country
Austria
Facility Name
CCBR A/S
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
CCBR A/S
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Facility Name
Frederiksberg Hospital Parker Institute
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
CCBR A/S
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinische Forschung Berlin-Buch GmbH
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Viereck-Apotheke
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum Apotheke
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
ClinPharm International GmbH
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Herz Apotheke
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Synexus ClinPharm GmbH
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Synexus ClinPharm GmbH / Frankfurt/M
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Facility Name
Schiller-Apotheke
City
Goppingen
ZIP/Postal Code
73033
Country
Germany
Facility Name
Schmerz und Palliativ-Zentrum Goppingen
City
Goppingen
ZIP/Postal Code
73033
Country
Germany
Facility Name
Falken Apotheke Hoheluft
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Klinische Forschung Hamburg GmbH
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Klinische Forschung Hannover-Mitte GmbH
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Löwen Apotheke
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Synexus ClinPharm GmbH
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Arkana Apotheke OHG
City
Leipzig
ZIP/Postal Code
04315
Country
Germany
Facility Name
Synexus ClinPharm GmbH Pruefzentrum Magdeburg
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Apotheke im MSZ
City
Magdeburg
ZIP/Postal Code
39112
Country
Germany
Facility Name
Schwanen Apotheke am Markt
City
Offenbach am Main
ZIP/Postal Code
63065
Country
Germany
Facility Name
Klinische Forschung Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Sonnenapotheke
City
Schwerin
ZIP/Postal Code
19057
Country
Germany
Facility Name
Nzoz Centrum Medyczne
City
Bialystok
ZIP/Postal Code
15-337
Country
Poland
Facility Name
Szpital Specjalistyczny im. J. Dietla
City
Krakow
ZIP/Postal Code
30-119
Country
Poland
Facility Name
NZOZ REUMED Sp.zo.o.
City
Lublin
ZIP/Postal Code
20 607
Country
Poland
Facility Name
Medyczne Centrum Hetmanska
City
Poznan
ZIP/Postal Code
60-218
Country
Poland
Facility Name
NZOZ "Nasz Lekarz"
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centrum Medyczne OSTEOMED NZOZ
City
Warszawa
ZIP/Postal Code
02-256
Country
Poland
Facility Name
Hospital Nuestra Senora de la Esperanza
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15705
Country
Spain
Facility Name
Complejo Hospitalario Universitario de A Coruna
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya (Hospital Civil)
City
Malaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya (Hospital Civil)
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Me3plus AB
City
Goteborg
ZIP/Postal Code
400 14
Country
Sweden
Facility Name
Me3plus AB
City
Goteborg
ZIP/Postal Code
412 63
Country
Sweden
Facility Name
Avdelningen for klinisk provning, Sahlgrenska Universitetssjukhuset
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Center for Clinical Studies
City
Malmö
ZIP/Postal Code
211 52
Country
Sweden
Facility Name
Bragee Medect AB
City
Stockholm
ZIP/Postal Code
115 22
Country
Sweden

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
23707270
Citation
Spierings ELH, Fidelholtz J, Wolfram G, Smith MD, Brown MT, West CR. A phase III placebo- and oxycodone-controlled study of tanezumab in adults with osteoarthritis pain of the hip or knee. Pain. 2013 Sep;154(9):1603-1612. doi: 10.1016/j.pain.2013.04.035. Epub 2013 Apr 22.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091030&StudyName=Tanezumab%20In%20Osteoarthritis%20Of%20The%20Hip%20Or%20Knee
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Tanezumab In Osteoarthritis Of The Hip Or Knee

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