Study Stopped
See termination reason in detailed description.
Tanezumab In Osteoarthritis Of The Hip Or Knee
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
3 other identifiers
interventional
614
7 countries
112
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2009
Shorter than P25 for phase_3
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2009
CompletedFirst Posted
Study publicly available on registry
September 28, 2009
CompletedStudy Start
First participant enrolled
October 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2011
CompletedResults Posted
Study results publicly available
May 14, 2021
CompletedMay 14, 2021
April 1, 2021
1.1 years
September 25, 2009
April 20, 2021
April 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline, Week 8
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.
Baseline, Week 8
Secondary Outcomes (44)
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population
Baseline, Weeks 2, 4, 12, and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: mITT Population
Baseline, Weeks 2, 4, 12, and 16
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
Baseline, Week 2, 4, 8, 12, and 16
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
Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population
Baseline, Weeks 2, 4, 8, 12, and 16
- +39 more secondary outcomes
Other Outcomes (1)
Number of Participants With Intravenous (IV) Doses of Study Medication
Day 1 up to Week 16
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
ACTIVE COMPARATOR4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- osteoarthritis of the knee or hip according to Kellgren-Lawrence x-ray grade of 2
You may not qualify if:
- pregnancy or intent to become pregnant
- BMI greater than 39
- other severe pain, significant cardiac, neurological or psychiatric disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (112)
Achieve Clinical Research
Birmingham, Alabama, 35209, United States
Alabama Orthopaedic Clinics, PC
Mobile, Alabama, 36608, United States
Horizon Research Group, Inc.
Mobile, Alabama, 36608, United States
Arizona Research Center, Inc.
Phoenix, Arizona, 85023, United States
Osteoporosis Medical Center
Beverly Hills, California, 90211, United States
Med Frontier Clinical Research
Buena Park, California, 90620, United States
Providence Clinical Research
Burbank, California, 91505, United States
Valley Research
Fresno, California, 93720, United States
Apex Research Institute
Santa Ana, California, 92705, United States
Medvin Clinical Research
Van Nuys, California, 91405, United States
Advanced Radiology
Stamford, Connecticut, 06902, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Homestead Clinical Research Group, P.A.
Cutler Bay, Florida, 33189, United States
Riverside Clinical Research
Edgewater, Florida, 32132, United States
Florida Clinical Research Center, LLC
Fruitland Park, Florida, 34731, United States
Adult Medicine Specialists
Longwood, Florida, 32779, United States
Genesis Research International
Longwood, Florida, 32779, United States
Community Research Foundation, Inc.
Miami, Florida, 33155, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Advent Clinical Research Centers, Inc.
Pinellas Park, Florida, 33781, United States
Sarasota Center For Clinical Research
Sarasota, Florida, 34232, United States
Dale G. Bramlet, MD
St. Petersburg, Florida, 33703, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Laureate Clinical Research Group
Atlanta, Georgia, 30342, United States
Drug Studies America Inc.
Marietta, Georgia, 30060, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
North Goergia Internal Medicine
Woodstock, Georgia, 30189, United States
Americana Orthopedics
Boise, Idaho, 83702, United States
Sonora Clinical Research, LLC.
Boise, Idaho, 83702, United States
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, 46383, United States
Commonwealth Biomedical Research
Madisonville, Kentucky, 42431, United States
Mid-Atlantic Medical Research
Hollywood, Maryland, 20636, United States
Miray Medical Center
Brockton, Massachusetts, 02301, United States
MedVadis Research Corporation
Watertown, Massachusetts, 02472-3930, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Great Lakes Research Group, Incorporated
Bay City, Michigan, 48706, United States
The Center for Clinical Trials
Biloxi, Mississippi, 39531, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Midwest Minor Medical
Omaha, Nebraska, 68114, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Midwest Minor Medical
Omaha, Nebraska, 68127, United States
Midwest Minor Medical
Omaha, Nebraska, 68144, United States
Diagnostic Center of Medicine
Henderson, Nevada, 89052, United States
Office of Matthew Barton, MD
Las Vegas, Nevada, 89144, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Office of Andrew J. Porges, MD PC
Roslyn, New York, 11576, United States
MediSpect, LLC
Boone, North Carolina, 28607, United States
Crescent Medical Research
Salisbury, North Carolina, 28144, United States
Hilltop Medical Research Center
Cincinnati, Ohio, 45224, United States
Columbus Clinical Research
Columbus, Ohio, 43213, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, 19335-2620, United States
Piedmont Arthritis Clinic, PA
Greenville, South Carolina, 29601-3973, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
TriCities Medical Research
Bristol, Tennessee, 37620, United States
Appalachian Medical Research Inc.
Johnson City, Tennessee, 37604-1417, United States
ClinRx Research, LLC
Carrollton, Texas, 75007, United States
Tekton Research, Inc
Georgetown, Texas, 78628, United States
One Step Diagnostic (X-Ray Facility)
Houston, Texas, 77030, United States
Pioneer Research Solutions
Houston, Texas, 77098, United States
Leander Healthcare Center
Leander, Texas, 78641, United States
ClinRx Research
Richardson, Texas, 75080, United States
Oakwell Clinical research, LLC
San Antonio, Texas, 78218, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
LKH/Universitatsklinikum Graz
Graz, A-8036, Austria
Nuhr Zentrum
Senftenberg, A-3541, Austria
ClinPharm International GmbH
Vienna, A-1090, Austria
Synexus ClinPharm GmbH
Vienna, A-1090, Austria
Rheuma Zentrum Favoriten
Vienna, A-1100, Austria
CCBR A/S
Aalborg, 9000, Denmark
CCBR A/S
Ballerup Municipality, 2750, Denmark
Frederiksberg Hospital Parker Institute
Frederiksberg, 2000, Denmark
CCBR A/S
Vejle, 7100, Denmark
Charité Universitätsmedizin Berlin
Berlin, 10117, Germany
Klinische Forschung Berlin-Buch GmbH
Berlin, 13125, Germany
Viereck-Apotheke
Berlin, 13125, Germany
Charité Campus Virchow-Klinikum Apotheke
Berlin, 13353, Germany
ClinPharm International GmbH
Bochum, 44787, Germany
Herz Apotheke
Bochum, 44787, Germany
Synexus ClinPharm GmbH
Bochum, 44787, Germany
Synexus ClinPharm GmbH / Frankfurt/M
Frankfurt am Main, 60596, Germany
Schiller-Apotheke
Göppingen, 73033, Germany
Schmerz und Palliativ-Zentrum Goppingen
Göppingen, 73033, Germany
Falken Apotheke Hoheluft
Hamburg, 20253, Germany
Klinische Forschung Hamburg GmbH
Hamburg, 20253, Germany
Klinische Forschung Hannover-Mitte GmbH
Hanover, 30159, Germany
Löwen Apotheke
Hanover, 30159, Germany
Synexus ClinPharm GmbH
Leipzig, 04103, Germany
Arkana Apotheke OHG
Leipzig, 04315, Germany
Synexus ClinPharm GmbH Pruefzentrum Magdeburg
Magdeburg, 39104, Germany
Apotheke im MSZ
Magdeburg, 39112, Germany
Schwanen Apotheke am Markt
Offenbach, 63065, Germany
Klinische Forschung Schwerin GmbH
Schwerin, 19055, Germany
Sonnenapotheke
Schwerin, 19057, Germany
Nzoz Centrum Medyczne
Bialystok, 15-337, Poland
Szpital Specjalistyczny im. J. Dietla
Krakow, 30-119, Poland
NZOZ REUMED Sp.zo.o.
Lublin, 20 607, Poland
Medyczne Centrum Hetmanska
Poznan, 60-218, Poland
NZOZ "Nasz Lekarz"
Torun, 87-100, Poland
Centrum Medyczne OSTEOMED NZOZ
Warsaw, 02-256, Poland
Hospital Nuestra Senora de la Esperanza
Santiago de Compostela, A Coruña, 15705, Spain
Complejo Hospitalario Universitario de A Coruna
A Coruña, 15006, Spain
Hospital Regional Universitario Carlos Haya (Hospital Civil)
Málaga, 29009, Spain
Hospital Regional Universitario Carlos Haya (Hospital Civil)
Málaga, 29010, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Me3plus AB
Gothenburg, 400 14, Sweden
Me3plus AB
Gothenburg, 412 63, Sweden
Avdelningen for klinisk provning, Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45, Sweden
Center for Clinical Studies
Malmo, 211 52, Sweden
Bragee Medect AB
Stockholm, 115 22, Sweden
Related Publications (3)
Brown MT, Cornblath DR, Koltzenburg M, Gorson KC, Hickman A, Pixton GC, Gaitonde P, Viktrup L, West CR. Peripheral Nerve Safety of Nerve Growth Factor Inhibition by Tanezumab: Pooled Analyses of Phase III Clinical Studies in Over 5000 Patients with Osteoarthritis. Clin Drug Investig. 2023 Jul;43(7):551-563. doi: 10.1007/s40261-023-01286-3. Epub 2023 Jul 18.
PMID: 37460782DERIVEDTive 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.
PMID: 30936738DERIVEDSpierings 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.
PMID: 23707270DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to the US FDA imposed clinical hold (effective 23 June 2010), study was terminated early and planned sample size was not reached. The primary time-point was changed from Week 16 to Week 8, as per change in planned analysis.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2009
First Posted
September 28, 2009
Study Start
October 30, 2009
Primary Completion
December 13, 2010
Study Completion
February 4, 2011
Last Updated
May 14, 2021
Results First Posted
May 14, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
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.