Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
697 participants
INTERVENTIONAL
2008-09-15
2010-01-14
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
DOUBLE
Study Groups
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Tanezumab 10 mg
tanezumab
IV tanezumab 10 mg at 1 dose every 8 weeks
Tanezumab 5 mg
tanezumab
IV tanezumab 5 mg at 1 dose every 8 weeks
Tanezumab 2.5 mg
tanezumab
IV tanezumab 2.5 mg at 1 dose every 8 weeks
Placebo
Placebo
IV placebo to match tanezumab at 1 dose every 8 weeks
Interventions
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tanezumab
IV tanezumab 10 mg at 1 dose every 8 weeks
tanezumab
IV tanezumab 5 mg at 1 dose every 8 weeks
tanezumab
IV tanezumab 2.5 mg at 1 dose every 8 weeks
Placebo
IV placebo to match tanezumab at 1 dose every 8 weeks
Eligibility Criteria
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Inclusion Criteria
* Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for knee injections arthroplasty or replace surgery.
* Pain level and function levels as required by the protocol at Screening and Baseline.
* Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study.
* Must agree to the contraceptive requirements of the protocol if applicable.
* Must agree to the treatment plan, scheduled visits, and procedures of the protocol.
Exclusion Criteria
* BMI greater than 39
* other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results
18 Years
99 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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Arizona Research Center, Inc.
Phoenix, Arizona, United States
Clinical Research Center of Connecticut
Danbury, Connecticut, 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
Avail Clinical Rearch, LLC
DeLand, Florida, United States
Avail Clinical Research
DeLand, Florida, United States
Arthritis Associates of South Florida, Clinical Research Center
Delray Beach, Florida, United States
Delray Research Associates
Delray Beach, Florida, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
Neurorehabilitation & Diagnostic Services
Miami, Florida, United States
Pharmax Research Clinic, LLC
Miami, Florida, United States
South Medical Research Group
Miami, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
The Arthritis Center
Palm Harbor, Florida, United States
University Clinical Research Incorporated
Pembroke Pines, Florida, United States
Advent Clinical Research Centers
Pinellas Park, Florida, United States
AVIVOCLIN Clinical Services
Port Orange, Florida, United States
Dale G. Bramlet, MD, P.L
St. Petersburg, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Laureate Clinical Reseach Group
Atlanta, Georgia, United States
Jefrey D. Lieberman, MD, PC
Decatur, Georgia, United States
Early Family Practice Center
Fort Valley, Georgia, United States
North Georgia Clinical Research
Marietta, 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
The Arthritis Center
Springfield, Illinois, United States
Memorial Health System, Inc./ Michiana Arthritis & Osteoporosis Center
South Bend, Indiana, United States
Memorial Health System, Inc.
South Bend, Indiana, United States
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, United States
Arthritis Center of Lexington
Lexington, Kentucky, United States
Bluegrass Community Research, Inc
Lexington, Kentucky, United States
David H. Neustadt P.S.C.
Louisville, Kentucky, United States
Gulf Coast Research, LLC
Baton Rouge, Louisiana, United States
The Baton Rouge Clinic
Baton Rouge, Louisiana, United States
Arthritis and Diabetes Clinic
Monroe, Louisiana, United States
Maine Research Associates
Auburn, Maine, United States
Office of Peter A. Holt, MD
Baltimore, Maryland, United States
The Arthritis and Osteoporosis Center of Maryland
Frederick, Maryland, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Mansfield Health Center
Mansfield, Massachusetts, United States
Arthritis Associates Inc.
Peabody, Massachusetts, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Ann Arbor Clinical Research
Ann Arbor, Michigan, United States
KMED Research
Saint Clair Shores, Michigan, United States
MAPS Applied Research Center
Edina, Minnesota, United States
Medical Advanced Pain Specialists
Edina, Minnesota, United States
Mercy Health Research
St Louis, Missouri, United States
Clinical Research Consortium
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
Health Sciences Research Center at Asthma & Allergy Assoc., PC
Elmira, New York, United States
Health Sciences Research Center at Asthma and Allergy Associates P.C.
Ithaca, New York, United States
The Medical Research Network, LLC
New York, New York, United States
Prem C. Chatpar, MD, LLC
Plainview, New York, United States
AAIR Research Center
Rochester, New York, United States
Arthristis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, United States
Pharmquest
Greensboro, North Carolina, United States
C.A.R.E. Center
Raleigh, North Carolina, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 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,Inc
Zanesville, Ohio, United States
Health Research Institute
Oklahoma City, Oklahoma, United States
EPIC Imaging West
Beaverton, Oregon, United States
EPIC Imaging East:
Portland, Oregon, United States
Covance CRU, Inc.
Portland, Oregon, United States
East Penn Rheumatology Associates, PC
Bethlehem, Pennsylvania, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Health Concepts
Rapid City, South Dakota, United States
Appalachian Medical Research
Johnson City, Tennessee, United States
Walter Chase, MD
Austin, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Radiant Research
San Antonio, Texas, United States
Texas Arthritis Research Center, PA
San Antonio, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Charlottesville Medical Research
Charlottesville, 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.
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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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P3 OA KNEE
Identifier Type: OTHER
Identifier Source: secondary_id
A4091011
Identifier Type: -
Identifier Source: org_study_id
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