Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
832 participants
INTERVENTIONAL
2009-05-05
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
tanezumab 10 mg
tanezumab 10 mg one dose at weeks 0 and 8
2
tanezumab 5 mg
tanezumab 5 mg one dose at weeks 0 and 8
3
naproxen
naproxen 1000 mg daily for 16 weeks
4
placebo
placebo to match tanezumab and naproxen dosing
Interventions
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tanezumab 10 mg
tanezumab 10 mg one dose at weeks 0 and 8
tanezumab 5 mg
tanezumab 5 mg one dose at weeks 0 and 8
naproxen
naproxen 1000 mg daily for 16 weeks
placebo
placebo to match tanezumab and naproxen dosing
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* BMI greater than 39
* other severe pain, significant cardiac, neurologic or cardiac disease
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Anniston Medical Clinic, PC
Anniston, Alabama, United States
Pinnaccle Research Group, LLC
Anniston, Alabama, United States
Clinical Research Advantage, Inc. / Mesa Family Medical Center, PC
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Paradise Valley, Arizona, United States
Pivotal Research Centers
Peoria, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Phoenix, Arizona, United States
University of Arizona - Arizona Arthritis Center
Tucson, Arizona, United States
University of Arizona
Tucson, Arizona, United States
St. Joseph's Mercy Clinic
Hot Springs, Arkansas, United States
Osteoporosis Medical Center
Beverly Hills, California, United States
Valley Research
Fresno, California, United States
Talbert Medical Group
Huntington Beach, California, United States
UC Davis Medical Center
Sacramento, California, United States
Lawrence P McAdam, MD / A Medical Corporation
Thousand Oaks, California, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Javed Rheumatology Associates, Inc.
Newark, Delaware, United States
Innovative Research of West Florida, Inc
Clearwater, Florida, United States
Tampa Bay Medical Research, Inc.
Clearwater, Florida, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
Adult Medicine Specialists
Longwood, Florida, United States
Genesis Research International
Longwood, Florida, United States
Kendall South Medical Center, Inc
Miami, Florida, United States
The Arthritis Center
Palm Harbor, Florida, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Arthritis and Rheumatology of Georgia
Atlanta, Georgia, United States
Jeffrey D. Lieberman, MD
Decatur, Georgia, United States
Marietta Rheumatology
Marietta, Georgia, United States
Physician Pain Care
Woodstock, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
North Georgia Internal Medicine
Woodstock, Georgia, United States
Sonora Clinical Research
Boise, Idaho, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Koch Family Practice
Morton, Illinois, United States
Illinois Bone and Joint Institute, LLC
Morton Grove, Illinois, United States
The Arthritis Center
Springfield, Illinois, United States
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, United States
McFarland Clinic, PC
Ames, Iowa, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, United States
David H. Neustadt, PSC
Louisville, Kentucky, United States
Stanocola Medical Center
Baton Rouge, Louisiana, United States
Maine Research Associates
Auburn, Maine, United States
Arthritis and Osteoporosis Center of Maryland
Frederick, Maryland, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Shores Rheumatology, P.C.
Saint Clair Shores, Michigan, United States
MAPS Applied Research Center, Inc
Edina, Minnesota, United States
Medical Advanced Pain Specialists
Edina, Minnesota, United States
Mercy Health Research
St Louis, Missouri, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, United States
Clinical Research Consortium
Las Vegas, Nevada, United States
Mirkil Medical
Las Vegas, Nevada, United States
G. Timothy Kelly, MD
Las Vegas, Nevada, United States
Michael Clifford, MD
Las Vegas, Nevada, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
New Mexico Clinical Research & Osteoporosis Center, Incorporated
Albuquerque, New Mexico, United States
The Medical Research Network, LLC
New York, New York, United States
AAIR Research Center
Rochester, New York, United States
Andrew J. Porges, MD, PC
Roslyn, New York, United States
Carolina Bone and Joint, PA
Charlotte, North Carolina, United States
Pharmquest
Greensboro, North Carolina, United States
Odyssey Research
Fargo, North Dakota, United States
Plains Medical Clinic, LLC
Fargo, North Dakota, United States
Hightop Medical Research Center
Cincinnati, Ohio, United States
Hilltop Physicians Inc / Hightop Medical Research Center
Cincinnati, Ohio, United States
Southwest Rheumatology and Research Group, LLC
Middleburg Heights, Ohio, United States
Pharmacotherapy Research Associates Incorporated
Zanesville, Ohio, United States
Health Research Institute
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Health Concepts
Rapid City, South Dakota, United States
Appalachian Medical Research, Inc
Johnson City, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Capitol Medical Clinic
Austin, Texas, United States
Office of Walter F Chase, MD, PA
Austin, Texas, United States
North Texas Joint Care, PA
Dallas, Texas, United States
Asif Cochinwala, MD, PA
Houston, Texas, United States
Pioneer Research Solutions, Inc
Houston, Texas, United States
Radiant Research San Antonio Northeast
San Antonio, Texas, United States
Diagnostic Research Group
San Antonio, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
South Texas Radiology Group
San Antonio, Texas, United States
Aspen Clinical Research, LLC
Orem, Utah, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, United States
Arthritis and Rheumatic Diseases
Portsmouth, Virginia, United States
Clinical Trials Northwest
Yakima, Washington, United States
Countries
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References
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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.
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.
Ekman EF, Gimbel JS, Bello AE, Smith MD, Keller DS, Annis KM, Brown MT, West CR, Verburg KM. Efficacy and safety of intravenous tanezumab for the symptomatic treatment of osteoarthritis: 2 randomized controlled trials versus naproxen. J Rheumatol. 2014 Nov;41(11):2249-59. doi: 10.3899/jrheum.131294. Epub 2014 Oct 1.
Other Identifiers
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P3 OA KNEE NSAID POPULATION
Identifier Type: OTHER
Identifier Source: secondary_id
A4091015
Identifier Type: -
Identifier Source: org_study_id
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