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Long Term Safety Study of Tanezumab in Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Tanezumab 20 mg

Tanezumab 10 mg

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain monoclonal antibody nerve growth factor

Eligibility Criteria

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

Inclusion Criteria:

Written informed consent prior to completing any of the study procedures.
Female patients must meet one of the following criteria:
1) Female patients of non childbearing potential - Must be post menopausal, defined as women who are >=45 years old with amenorrhea for 24 consecutive months (regardless of FSH levels), or women who are amenorrheic for at least 1 year AND have a serum Follicle Stimulating Hormone (FSH) level greater than 30 IU/L at Screening for the parent double blind CLBP study; or Must be surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy.
2.) Female patients of child bearing potential: must not be pregnant or lactating, and must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method), and must have a negative serum pregnancy test at Screening (within 30 days prior to Baseline) and a negative urine pregnancy test at Baseline prior to initial dosing
Male patients must agree that they and their female spouses / partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non childbearing potential.
Females of child bearing potential and males must be willing to use approved methods of contraception from commencement of screening procedures until 16 weeks after the last dose of IV study medication.
Patient must be able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures
Patient has been treated in a parent tanezumab double blind CLBP study
Patient has completed the Preferred Rollover Time Point visit of the double blind CLBP parent study or has been withdrawn for lack of efficacy. At least eight weeks but no more than 12 weeks have elapsed since the last study medication infusion in the parent study. Patients are permitted to enter the extension study up to 12 weeks after their last dose of study medication in their parent study (or 4 weeks after the End of Treatment visit)

Exclusion Criteria:

Failed screening in a parent tanezumab double blind CLBP study
Withdrawn from a parent tanezumab double blind CLBP study for an adverse event
Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to become pregnant during the course of clinical study
Use of any investigational medication within 30 days prior to Baseline (3 months for any investigational biological other than tanezumab) or plans to receive an investigational medication other than the study medication during the course of this study
Patients who exited the parent double blind CLBP study because of lack of compliance, protocol violation (including not meeting entrance criteria), no longer willing to participate (for reasons other than lack of efficacy), or were lost to follow up in the parent double blind study
Patients who were randomized into the parent study in violation of inclusion or exclusion criteria but who were not withdrawn from the parent study;
Any other condition, which in the opinion of the Investigator, would put the patient at increased safety risk or otherwise make the patient unsuitable for this study

Sites / Locations

Pinnacle Research Group, LLC
Pinnacle Research Group, Anniston Medical Clinic
Pinnacle Research Group
Simon Williamson Clinic, PC
Simon-Williamson Clinic, PC
Saadat Ansari, MD
Alabama Orthopaedic Clinic
Horizon Research Group
Phoenix Diagnostic Imaging
Radiant Research - Phoenix Southeast
Simon Med
Pivotal Research Centers
Sun Radiology
Arizona Research Center, LLC
Radiant Research
Scottsdale Medical Imaging
Premiere Phamaceutical Research, LLC
Clinical Research Advantage, Inc./Fiel Family and Sports Medicine, PC
Little Rock Family Practice Clinic
Providence Clinical Research
Valley Research
Collaborative Neuroscience Network, Inc.
University of California San Diego
Samaritan Center for Medical Research Medical Group
Newport Diagnostic Center
North County Clinical Research (NCCR)
Advances in Medicine
Trinity Medical Research
Center for Clinical Trials of Sacramento, Inc.
Wetlin Research Associates, Inc
Inland Rheumatology & Osteoporosis Medical Group, Inc.
Elite Clinical Trials, Inc.
Alpine Clinical Research Center
Clinicos, LLC
Advanced Radiology
Stamford Therapeutics Consortium
New England Research Associates, LLC
Southeast Clinical Research, LLC
Southeast Clinical Research
Doctors Medical Center
Avail Clinical Research, LLC
SJS Clinical Research, Inc.
Jacksonville Center for Clinical Research
Southeast Clinical Research, LLC
Collier Neurologic Specialists
Compass Research, LLC
Palm Beach Gardens Open Imaging Center
University Clinical Research
Advent Clinical Research Center
Meridien Research
St Petersburg General Hospital - X-Rays only
Dale G. Bramlet, MD., P.L.
Miami Research Associates
Palm Beach Research Center
MD Now Urgent Care
Midtown Imaging
Center for Prospective Outcome Studies
Southeastern Radiology Associates, LLC
River Birch Research Alliance, LLC
CT: Marietta Imaging Center LLC
Drug Studies America
Selah Medical Center, PA
Advanced Diagnostic Imaging (ADI)
MediSphere Medical Research Center, LLC
Diagnostic Imaging Centers
Clinical Trials Technology, Inc.
Cotton-O'Neil Clinical Research Center
Cotton-O'Neil Clinic
Central Kentucky Research Associates, Inc.
Commonwealth Biomedical Research
Arthritis and Diabetes Clinic
Office of Peter A. Holt, MD
Clinical Pharmacology Study Group
The Center for Clinical Trials
Clinical Research Center of Jackson
Physician's Surgery Center
Medex Healthcare Research, Inc.
Mercy Health Research
Clinvest, A Division of Banyan Group, Inc
Quality Clinical Research, Inc.
Meridian Clinical Research, LLC
Clinical Research Consortium
Mirkil Medical
Advanced Biomedical Research of America
Comprehensive Clinical Research
Booth Radiology
CRI Worldwide, LLC
Albuquerque Clinical Trials, Inc.
Central New York Clinical Research
Medex Healthcare Research
The Medical Research Network, LLC
B & I Imaging
Rochester Clinical Research, Inc.
Finger Lakes Clinical Research
Upstate Clinical Research Associates
Greensboro Imaging
Pharmquest
Caldwell Memorial Hospital
Northstate Clinical Research, PLLC
Wake Internal Medicine Consultants, Inc.
Wake Research Associates, LLC
The Center for Clinical Research
Rapid Medical Research, Inc.
Christine Codding, MD
Health Research of Oklahoma
McBride Clinic, Inc
Lynn Health Science Institute
Medford Medical Clinic, LLP
Rogue Valley Medical Center
Sunstone Research
Summit Research Network (Oregon), Inc.
Allegheny Pain Management
Blair Medical Associates-Radiology
Paramount Clinical Research
Altoona Center for Clinical Research
CRI Worldwide LLC
New England Center for Clinical Research
Omega Medical Research
Columbia Arthritis Center, P.A.
Southern Orthopaedic Sports Medicine
Radiant Research
Health Concepts
SCRI Research Center, LLC
Wolf River Medical Group, LLC
Advanced Therapeutics, Inc.
FutureSearch Trials of Neurology
DiscoveResearch, Inc.
Beaumont Internal Medicine & Geriatric Associates
DiscoveResearch Incorporated
Punzi Medical Center
KRK Medical Research
Advances In Health, Inc.
St. Luke's Diagnostic & Treatment Center Kirby Glen
Centex Research Inc.
Centex Research
Centex Research
Paragon Research Center
Office of Theresia Lee, MD
Progressive Clinical Research
Sendero Imaging and Treatment Center
J. Lewis Research, Inc.
J. Lewis Research, Incorporated/Foothill Family Clinic South
Charlottesville Medical Research
Chesapeake Regional Imaging Center-Kempsville
Hampton Road Center for Clinical Research
National Clinical Research - Richmond
Virginia Beach Radiology
Advanced Pain Management
Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Tanezumab 20 mg

Tanezumab 10 mg

Arm Description

Outcomes

Primary Outcome Measures

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

AE: any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE: AE resulting in any of 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 medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state.

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4

NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 56

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4

BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 56

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4

BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 56

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score was calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 8

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 16

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 24

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 32

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 40

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 48

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 56

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4

Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 8

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 16

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 24

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 32

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 40

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 48

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 56

Secondary Outcome Measures

Time to Discontinuation Due to Lack of Efficacy

Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.

Plasma Concentration of Tanezumab

Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero.

Total Nerve Growth Factor (NGF) Concentration

Full Information

NCT ID

NCT00924664

First Posted

June 18, 2009

Last Updated

March 25, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00924664

Brief Title

Long Term Safety Study of Tanezumab in Chronic Low Back Pain

Official Title

A RANDOMIZED, MULTICENTER, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC LOW BACK PAIN

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Terminated

Why Stopped

See termination reason in detailed description.

Study Start Date

August 20, 2009 (Actual)

Primary Completion Date

November 30, 2010 (Actual)

Study Completion Date

June 22, 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 safety and efficacy of tanezumab for chronic low back pain. Patients who were randomized and treated with study medication in a previous chronic low back pain "parent" study will be eligible to enroll in this safety extension study at the Preferred Rollover Time Point visit or at the Early Termination visit of the parent study upon discontinuation due to lack of efficacy.

Detailed Description

This study was terminated on 30 November 2010 following a US FDA clinical hold for tanezumab chronic low back pain clinical studies which halted dosing and enrollment of patients on 19 July 2010 for potential safety issues.

6. Conditions and Keywords

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

Low Back Pain

Keywords

low back pain monoclonal antibody nerve growth factor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

849 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tanezumab 20 mg

Arm Type

Experimental

Arm Title

Tanezumab 10 mg

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Tanezumab 20 mg

Intervention Description

Tanezumab 20 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks

Intervention Type

Biological

Intervention Name(s)

Tanezumab 10 mg

Intervention Description

Tanezumab 10 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline up to 112 days after last dose of study treatment (up to 448 days)

Title

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4

Description

Time Frame

A4091012: Baseline, A4091039: Week 4

Title

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8

Description

Time Frame

A4091012: Baseline, A4091039: Week 8

Title

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16

Description

Time Frame

A4091012: Baseline, A4091039: Week 16

Title

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24

Description

Time Frame

A4091012: Baseline, A4091039: Week 24

Title

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32

Description

Time Frame

A4091012: Baseline, A4091039: Week 32

Title

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40

Description

Time Frame

A4091012: Baseline, A4091039: Week 40

Title

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48

Description

Time Frame

A4091012: Baseline, A4091039: Week 48

Title

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 56

Description

Time Frame

A4091012: Baseline, A4091039: Week 56

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4

Description

Time Frame

A4091012: Baseline, A4091039: Week 4

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8

Description

Time Frame

A4091012: Baseline, A4091039: Week 8

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16

Description

Time Frame

A4091012: Baseline, A4091039: Week 16

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24

Description

Time Frame

A4091012: Baseline, A4091039: Week 24

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32

Description

Time Frame

A4091012: Baseline, A4091039: Week 32

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40

Description

Time Frame

A4091012: Baseline, A4091039: Week 40

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48

Description

Time Frame

A4091012: Baseline, A4091039: Week 48

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 56

Description

Time Frame

A4091012: Baseline, A4091039: Week 56

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4

Description

Time Frame

A4091012: Baseline, A4091039: Week 4

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8

Description

Time Frame

A4091012: Baseline, A4091039: Week 8

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16

Description

Time Frame

A4091012: Baseline, A4091039: Week 16

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24

Description

Time Frame

A4091012: Baseline, A4091039: Week 24

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32

Description

Time Frame

A4091012: Baseline, A4091039: Week 32

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40

Description

Time Frame

A4091012: Baseline, A4091039: Week 40

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48

Description

Time Frame

A4091012: Baseline, A4091039: Week 48

Title

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 56

Description

Time Frame

A4091012: Baseline, A4091039: Week 56

Title

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4

Description

Time Frame

A4091012: Baseline, A4091039: Week 4

Title

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 8

Description

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Time Frame

A4091012: Baseline, A4091039: Week 8

Title

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 16

Description

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Time Frame

A4091012: Baseline, A4091039: Week 16

Title

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 24

Description

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Time Frame

A4091012: Baseline, A4091039: Week 24

Title

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 32

Description

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Time Frame

A4091012: Baseline, A4091039: Week 32

Title

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 40

Description

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Time Frame

A4091012: Baseline, A4091039: Week 40

Title

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 48

Description

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Time Frame

A4091012: Baseline, A4091039: Week 48

Title

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 56

Description

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Time Frame

A4091012: Baseline, A4091039: Week 56

Title

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4

Description

Time Frame

A4091012: Baseline, A4091039: Week 4

Title

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 8

Description

Time Frame

A4091012: Baseline, A4091039: Week 8

Title

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 16

Description

Time Frame

A4091012: Baseline, A4091039: Week 16

Title

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 24

Description

Time Frame

A4091012: Baseline, A4091039: Week 24

Title

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 32

Description

Time Frame

A4091012: Baseline, A4091039: Week 32

Title

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 40

Description

Time Frame

A4091012: Baseline, A4091039: Week 40

Title

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 48

Description

Time Frame

A4091012: Baseline, A4091039: Week 48

Title

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 56

Description

Time Frame

A4091012: Baseline, A4091039: Week 56

Secondary Outcome Measure Information:

Title

Time to Discontinuation Due to Lack of Efficacy

Description

Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.

Time Frame

Baseline up to Week 56

Title

Plasma Concentration of Tanezumab

Description

Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero.

Time Frame

Baseline (Day 1), Week 8, 24, 40, 56, 64

Title

Total Nerve Growth Factor (NGF) Concentration

Time Frame

Baseline (Day 1), Week 8, 24, 40, 56, 64

Other Pre-specified Outcome Measures:

Title

Number of Participants Using Concomitant Medication for Chronic Low Back Pain (CLBP)

Description

Food and Drug Administration (FDA) approved analgesics and muscle relaxants were permitted as concomitant medications for CLBP and were prescribed as per investigator's discretion. These medications included opioids, topical analgesics, non-steroidal anti-inflammatory drug (NSAIDs), capsaicin products, oral/injectable corticosteroids, and viscosupplementation (eg, hyaluronan).

Time Frame

Baseline up to Week 56

Title

Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56

Description

WPAI:SHP: 6-item, binary question on current employment, 3 questions on hours of work and work-loss, 2 questions based on 0-10 point scale to judge how CLBP affects ability to work, perform regular activities(0=no effect on work/activity, 10=completely prevented from working/activity). Four scores derived as percent: activity impairment, impairment while working, overall work impairment, work time missed. Total possible score: 0-100 (0=no impairment/high productivity, 100=completely impaired/low activity). Each of 4 scores expressed as impairment percentages, high percentage=more impairment, less productivity.

Time Frame

A4091012: Baseline, A4091039: Week 24, 56

Title

Number of Participants Who Developed Anti-Tanezumab Antibodies

Description

Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.

Time Frame

Baseline (Day 1), Week 8, 24, 40, 56, 64

Title

Number of Participants With Injection and Infusion Site Reactions

Description

The injection and infusion site reactions were assessed based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after administration (not related to needle insertion pain) of subcutaneous injection or intravenous infusion.

Time Frame

Baseline (Day 1), Week 4, 8, 16, 24, 32 for intravenous infusion; Week 24, 32, 40, 56, 64 for subcutaneous injection

Title

Number of Participants With Intravenous and Subcutaneous Doses of Study Medication

Description

Number of participants are reported based on the maximum number of intravenous (IV) and subcutaneous (SC) doses of tanezumab received.

Time Frame

Day 1 up to Week 56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent prior to completing any of the study procedures. Female patients must meet one of the following criteria: 1) Female patients of non childbearing potential - Must be post menopausal, defined as women who are >=45 years old with amenorrhea for 24 consecutive months (regardless of FSH levels), or women who are amenorrheic for at least 1 year AND have a serum Follicle Stimulating Hormone (FSH) level greater than 30 IU/L at Screening for the parent double blind CLBP study; or Must be surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy. 2.) Female patients of child bearing potential: must not be pregnant or lactating, and must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method), and must have a negative serum pregnancy test at Screening (within 30 days prior to Baseline) and a negative urine pregnancy test at Baseline prior to initial dosing Male patients must agree that they and their female spouses / partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non childbearing potential. Females of child bearing potential and males must be willing to use approved methods of contraception from commencement of screening procedures until 16 weeks after the last dose of IV study medication. Patient must be able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures Patient has been treated in a parent tanezumab double blind CLBP study Patient has completed the Preferred Rollover Time Point visit of the double blind CLBP parent study or has been withdrawn for lack of efficacy. At least eight weeks but no more than 12 weeks have elapsed since the last study medication infusion in the parent study. Patients are permitted to enter the extension study up to 12 weeks after their last dose of study medication in their parent study (or 4 weeks after the End of Treatment visit) Exclusion Criteria: Failed screening in a parent tanezumab double blind CLBP study Withdrawn from a parent tanezumab double blind CLBP study for an adverse event Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to become pregnant during the course of clinical study Use of any investigational medication within 30 days prior to Baseline (3 months for any investigational biological other than tanezumab) or plans to receive an investigational medication other than the study medication during the course of this study Patients who exited the parent double blind CLBP study because of lack of compliance, protocol violation (including not meeting entrance criteria), no longer willing to participate (for reasons other than lack of efficacy), or were lost to follow up in the parent double blind study Patients who were randomized into the parent study in violation of inclusion or exclusion criteria but who were not withdrawn from the parent study; Any other condition, which in the opinion of the Investigator, would put the patient at increased safety risk or otherwise make the patient unsuitable for this study

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

Pinnacle Research Group, LLC

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36201

Country

United States

Facility Name

Pinnacle Research Group, Anniston Medical Clinic

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Pinnacle Research Group

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Simon Williamson Clinic, PC

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35211

Country

United States

Facility Name

Simon-Williamson Clinic, PC

City

Hueytown

State/Province

Alabama

ZIP/Postal Code

35023

Country

United States

Facility Name

Saadat Ansari, MD

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Alabama Orthopaedic Clinic

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Horizon Research Group

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Phoenix Diagnostic Imaging

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Radiant Research - Phoenix Southeast

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Simon Med

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85202

Country

United States

Facility Name

Pivotal Research Centers

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Sun Radiology

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Arizona Research Center, LLC

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

Radiant Research

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

Country

United States

Facility Name

Scottsdale Medical Imaging

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

Country

United States

Facility Name

Premiere Phamaceutical Research, LLC

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85282

Country

United States

Facility Name

Clinical Research Advantage, Inc./Fiel Family and Sports Medicine, PC

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85283

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

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

Collaborative Neuroscience Network, Inc.

City

Garden Grove

State/Province

California

ZIP/Postal Code

92845

Country

United States

Facility Name

University of California San Diego

City

La Jolla

State/Province

California

ZIP/Postal Code

92121

Country

United States

Facility Name

Samaritan Center for Medical Research Medical Group

City

Los Gatos

State/Province

California

ZIP/Postal Code

95032

Country

United States

Facility Name

Newport Diagnostic Center

City

Newport Beach

State/Province

California

ZIP/Postal Code

92660

Country

United States

Facility Name

North County Clinical Research (NCCR)

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Advances in Medicine

City

Rancho Mirage

State/Province

California

ZIP/Postal Code

92270

Country

United States

Facility Name

Trinity Medical Research

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

Center for Clinical Trials of Sacramento, Inc.

City

Sacramento

State/Province

California

ZIP/Postal Code

95823

Country

United States

Facility Name

Wetlin Research Associates, Inc

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

Inland Rheumatology & Osteoporosis Medical Group, Inc.

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Elite Clinical Trials, Inc.

City

Wildomar

State/Province

California

ZIP/Postal Code

92595

Country

United States

Facility Name

Alpine Clinical Research Center

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80304

Country

United States

Facility Name

Clinicos, LLC

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80904

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

New England Research Associates, LLC

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

Facility Name

Southeast Clinical Research, LLC

City

Chiefland

State/Province

Florida

ZIP/Postal Code

32626

Country

United States

Facility Name

Southeast Clinical Research

City

Chiefland

State/Province

Florida

ZIP/Postal Code

32626

Country

United States

Facility Name

Doctors Medical Center

City

DeFuniak Springs

State/Province

Florida

ZIP/Postal Code

32435

Country

United States

Facility Name

Avail Clinical Research, LLC

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

SJS Clinical Research, Inc.

City

Destin

State/Province

Florida

ZIP/Postal Code

32541

Country

United States

Facility Name

Jacksonville Center for Clinical Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Southeast Clinical Research, LLC

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Collier Neurologic Specialists

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Compass Research, LLC

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Palm Beach Gardens Open Imaging Center

City

Palm Beach Gardens

State/Province

Florida

ZIP/Postal Code

33410

Country

United States

Facility Name

University Clinical Research

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Advent Clinical Research Center

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

Facility Name

Meridien Research

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33709

Country

United States

Facility Name

St Petersburg General Hospital - X-Rays only

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33710

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

Miami Research Associates

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Palm Beach Research Center

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33404

Country

United States

Facility Name

MD Now Urgent Care

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

Midtown Imaging

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33417

Country

United States

Facility Name

Center for Prospective Outcome Studies

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30327

Country

United States

Facility Name

Southeastern Radiology Associates, LLC

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30327

Country

United States

Facility Name

River Birch Research Alliance, LLC

City

Blue Ridge

State/Province

Georgia

ZIP/Postal Code

30513

Country

United States

Facility Name

CT: Marietta Imaging Center LLC

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Drug Studies America

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Selah Medical Center, PA

City

Boise

State/Province

Idaho

ZIP/Postal Code

83704

Country

United States

Facility Name

Advanced Diagnostic Imaging (ADI)

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

MediSphere Medical Research Center, LLC

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Diagnostic Imaging Centers

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

Facility Name

Clinical Trials Technology, Inc.

City

Prairie Village

State/Province

Kansas

ZIP/Postal Code

66206

Country

United States

Facility Name

Cotton-O'Neil Clinical Research Center

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Cotton-O'Neil Clinic

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Central Kentucky Research Associates, Inc.

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40509

Country

United States

Facility Name

Commonwealth Biomedical Research

City

Madisonville

State/Province

Kentucky

ZIP/Postal Code

42431

Country

United States

Facility Name

Arthritis and Diabetes Clinic

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71203

Country

United States

Facility Name

Office of Peter A. Holt, MD

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21239

Country

United States

Facility Name

Clinical Pharmacology Study Group

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01610

Country

United States

Facility Name

The Center for Clinical Trials

City

Biloxi

State/Province

Mississippi

ZIP/Postal Code

39531

Country

United States

Facility Name

Clinical Research Center of Jackson

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

Physician's Surgery Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

Medex Healthcare Research, Inc.

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

Mercy Health Research

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Clinvest, A Division of Banyan Group, Inc

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Facility Name

Quality Clinical Research, Inc.

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Meridian Clinical Research, LLC

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Clinical Research Consortium

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

Mirkil Medical

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

Advanced Biomedical Research of America

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89123

Country

United States

Facility Name

Comprehensive Clinical Research

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

Facility Name

Booth Radiology

City

Stratford

State/Province

New Jersey

ZIP/Postal Code

08084

Country

United States

Facility Name

CRI Worldwide, LLC

City

Willingboro

State/Province

New Jersey

ZIP/Postal Code

08046

Country

United States

Facility Name

Albuquerque Clinical Trials, Inc.

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Central New York Clinical Research

City

Manlius

State/Province

New York

ZIP/Postal Code

13104

Country

United States

Facility Name

Medex Healthcare Research

City

New York

State/Province

New York

ZIP/Postal Code

10004

Country

United States

Facility Name

The Medical Research Network, LLC

City

New York

State/Province

New York

ZIP/Postal Code

10128

Country

United States

Facility Name

B & I Imaging

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Rochester Clinical Research, Inc.

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Finger Lakes Clinical Research

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

Upstate Clinical Research Associates

City

Williamsville

State/Province

New York

ZIP/Postal Code

14221

Country

United States

Facility Name

Greensboro Imaging

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27407

Country

United States

Facility Name

Pharmquest

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Caldwell Memorial Hospital

City

Lenoir

State/Province

North Carolina

ZIP/Postal Code

28645

Country

United States

Facility Name

Northstate Clinical Research, PLLC

City

Lenoir

State/Province

North Carolina

ZIP/Postal Code

28645

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, LLC

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

The Center for Clinical Research

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Rapid Medical Research, Inc.

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

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

McBride Clinic, Inc

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

Medford Medical Clinic, LLP

City

Medford

State/Province

Oregon

ZIP/Postal Code

95704

Country

United States

Facility Name

Rogue Valley Medical Center

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Sunstone Research

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Summit Research Network (Oregon), Inc.

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Allegheny Pain Management

City

Altoona

State/Province

Pennsylvania

ZIP/Postal Code

16602

Country

United States

Facility Name

Blair Medical Associates-Radiology

City

Altoona

State/Province

Pennsylvania

ZIP/Postal Code

16602

Country

United States

Facility Name

Paramount Clinical Research

City

Bridgeville

State/Province

Pennsylvania

ZIP/Postal Code

15017

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

CRI Worldwide LLC

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19139

Country

United States

Facility Name

New England Center for Clinical Research

City

Cranston

State/Province

Rhode Island

ZIP/Postal Code

02920

Country

United States

Facility Name

Omega Medical Research

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

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

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Health Concepts

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57702

Country

United States

Facility Name

SCRI Research Center, LLC

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Wolf River Medical Group, LLC

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Advanced Therapeutics, Inc.

City

Johnson City

State/Province

Tennessee

ZIP/Postal Code

37601

Country

United States

Facility Name

FutureSearch Trials of Neurology

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

DiscoveResearch, Inc.

City

Beaumont

State/Province

Texas

ZIP/Postal Code

77701

Country

United States

Facility Name

Beaumont Internal Medicine & Geriatric Associates

City

Beaumont

State/Province

Texas

ZIP/Postal Code

77702

Country

United States

Facility Name

DiscoveResearch Incorporated

City

Bryan

State/Province

Texas

ZIP/Postal Code

77802

Country

United States

Facility Name

Punzi Medical Center

City

Carrollton

State/Province

Texas

ZIP/Postal Code

75006

Country

United States

Facility Name

KRK Medical Research

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Advances In Health, Inc.

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

St. Luke's Diagnostic & Treatment Center Kirby Glen

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Centex Research Inc.

City

Houston

State/Province

Texas

ZIP/Postal Code

77062

Country

United States

Facility Name

Centex Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77065

Country

United States

Facility Name

Centex Research

City

Nassau Bay

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

Paragon Research Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78205

Country

United States

Facility Name

Office of Theresia Lee, MD

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Progressive Clinical Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Sendero Imaging and Treatment Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

J. Lewis Research, Inc.

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84109

Country

United States

Facility Name

J. Lewis Research, Incorporated/Foothill Family Clinic South

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84121

Country

United States

Facility Name

Charlottesville Medical Research

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22911

Country

United States

Facility Name

Chesapeake Regional Imaging Center-Kempsville

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Hampton Road Center for Clinical Research

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

National Clinical Research - Richmond

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Virginia Beach Radiology

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454-3033

Country

United States

Facility Name

Advanced Pain Management

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

Facility Name

Northwest Clinical Research Center

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98007

Country

United States

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

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

24937440

Citation

Gimbel JS, Kivitz AJ, Bramson C, Nemeth MA, Keller DS, Brown MT, West CR, Verburg KM. Long-term safety and effectiveness of tanezumab as treatment for chronic low back pain. Pain. 2014 Sep;155(9):1793-1801. doi: 10.1016/j.pain.2014.06.004. Epub 2014 Jun 14.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091039&StudyName=Long%20Term%20Safety%20Study%20of%20Tanezumab%20in%20Chronic%20Low%20Back%20Pain

Description

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

Learn more about this trial

Long Term Safety Study of Tanezumab in Chronic Low Back Pain

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