Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
849 participants
INTERVENTIONAL
2009-06-09
2010-08-16
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, neurological or psychiatric 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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Greystone Medical Research, LLC
Birmingham, Alabama, United States
Saadat Ansari, MD
Huntsville, Alabama, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Clinical Research Advantage, Inc. / Central Arizona Medical Associates, PC
Mesa, Arizona, United States
Novara Clinical Research
Mesa, Arizona, United States
Clinical Research Advantage, Inc.
Mesa, Arizona, United States
Central Phoenix Medical - Clinical Research Advantage
Phoenix, Arizona, United States
Paradigm Clinical, Inc
Tucson, Arizona, United States
eStudySite
Chula Vista, California, United States
Orthopedic Physicians of Colorado, PC
Englewood, California, United States
University Parks Hematology/Oncology
Englewood, California, United States
Edinger Medical Group and Research Center
Fountain Valley, California, United States
Valley Research
Fresno, California, United States
Lakewood Orthopedic Medical & Surgical Group
Lakewood, California, United States
High Desert Medical Group Research for Life
Lancaster, California, United States
Premiere Clinical Research, LLC
Long Beach, California, United States
Miracle Mile Medical Center
Los Angeles, California, United States
Samaritan Center for Medical Research
Los Gatos, California, United States
Del Carmen Medical Center
Reseda, California, United States
Probe Clinical Research, Corp.
Santa Ana, California, United States
Lawrence P.McAdam, MD, A Medical Corporation
Thousand Oaks, California, United States
Westlake Medical Center
Westlake Village, California, United States
Peak Anesthesia and Pain Management
Centennial, Colorado, United States
Denver Internal Medicine Group
Denver, Colorado, United States
Mountain View Clinical Research, Inc.
Denver, Colorado, United States
Colorado Hematology
Englewood, Colorado, United States
Colorado Orthopedic Consultants, PC
Englewood, Colorado, United States
American Clinical Research, LLC
Englewood, Colorado, United States
Norwalk Medical Group
Norwalk, Connecticut, United States
Rheumatology Consultants of Delaware
Lewes, Delaware, United States
HeartCare
Bradenton, Florida, United States
In Vivo Clinical Research, Inc
Doral, Florida, United States
S & W Clinical Research
Fort Lauderdale, Florida, United States
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, United States
Kendall South Medical Center, Inc
Miami, Florida, United States
Sunshine Research Center
Opa-locka, Florida, United States
Rheumatology Associates of Central Florida, PA
Orlando, Florida, United States
HeartCare Research
Sarasota, Florida, United States
Tampa Medical Group PA
Tampa, Florida, United States
Masters of Clinical Research, Inc.
Augusta, Georgia, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, United States
Millennium Pain Center
Bloomington, Illinois, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Pasadena Pharmacy
Lexington, Kentucky, United States
The Pain Treatment Center of the Bluegrass
Lexington, Kentucky, United States
L-Marc Research Center
Louisville, Kentucky, United States
Bone and Joint Clinic of Baton Rouge
Baton Rouge, Louisiana, United States
Gulf Coast Research, LLC
Baton Rouge, Louisiana, United States
Mid-Atlantic Medical Research Centers
Hollywood, Maryland, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, United States
Miray Medical Center
Brockton, Massachusetts, United States
Great Lakes Research Group, Incorporated
Bay City, Michigan, United States
Planters Clinic
Port Gibson, Mississippi, United States
St. John's Medical Research Institute, Inc.
Springfield, Missouri, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, United States
Diagnositc Center of Medicine
Henderson, Nevada, United States
Independent Clinical Researchers
Las Vegas, Nevada, United States
Wolfson Medical Center
Las Vegas, Nevada, United States
Clinical Research Consortium
Las Vegas, Nevada, United States
Medex Healthcare Research, Inc.
New York, New York, United States
SPRI Bronx LLC
The Bronx, New York, United States
Columbus Clinical Research, Inc.
Columbus, Ohio, United States
Providence Health Partners - Center for Clinical Research
Dayton, Ohio, United States
Orthopedic & Sports Medicine Consultants
Middletown, Ohio, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States
Physicians' Research, Inc
Zanesville, Ohio, United States
PrimeCare of Southeastern Ohio, Inc
Zanesville, Ohio, United States
Cor Clinical Research, LLC
Oklahoma City, Oklahoma, United States
The Family Healthcare Center, PA
Clinton, South Carolina, United States
Southern Orthopaedic Sports Medicine
Columbia, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Low Country Rheumatology, PA
North Charleston, South Carolina, United States
The Carolina Center for Rheumatology and Arthritis Care, PA
Rock Hill, South Carolina, United States
Palmetto Clinical Trial Services, LLC
Simpsonville, South Carolina, United States
South Austin Orthopedics
Austin, Texas, United States
Tekton Research Inc. - Research Office
Austin, Texas, United States
Texas Orthopedic Specialists
Grapevine, Texas, United States
Foundation for Southwest Orthopedic Research
Houston, Texas, United States
Southwest Orthopedic Group
Houston, Texas, United States
The Neurology Center
Houston, Texas, United States
Gill Orthopedic Center
Lubbock, Texas, United States
Robert R. King, M.D., PA
Lubbock, Texas, United States
AZ Clinical Research
Sugar Land, Texas, United States
Spring Clinical Research
Sugar Land, Texas, United States
Sugar Land Med-Ped, P.A.
Sugar Land, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Incorporated/Foothill Family Clinic South
Salt Lake City, Utah, United States
Commonwealth Orthopedics & Rehabilitation , P.C.
Arlington, Virginia, United States
IntegraTrials, LLC
Arlington, Virginia, United States
Virginia Hospital Center
Arlington, Virginia, United States
HypotheTest, LLC
Roanoke, Virginia, United States
Empirical Clinical Trials, LLC
Selah, Washington, United States
Arthritis Northwest, PLLC
Spokane, 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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A4091018
Identifier Type: -
Identifier Source: org_study_id
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