Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
220 participants
INTERVENTIONAL
2009-05-18
2010-11-16
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
DOUBLE
Study Groups
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Tanezumab 5 mg
tanezumab
5 mg dose Intravenously every 8 weeks for duration of study
Tanezumab 10 mg
tanezumab
10 mg dose Intravenously every 8 weeks for duration of study
Placebo
Placebo
Placebo, Intravenously, every 8 weeks for duration of study
Interventions
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tanezumab
5 mg dose Intravenously every 8 weeks for duration of study
tanezumab
10 mg dose Intravenously every 8 weeks for duration of study
Placebo
Placebo, Intravenously, every 8 weeks for duration of study
Eligibility Criteria
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Inclusion Criteria
* Osteoarthritis (arthritis) of the knee or hip with pain score that qualifies
* Willing to comply with study visit schedule and study requirements, including, for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control, one of which is a barrier method.
* Patients must consent in writing to participate in the study.
Exclusion Criteria
* Unwilling or unable to discontinue the use of prohibited medications, including other pain medications, during the screening period and during the study,
* Significant cardiac disease within the past 6 months
* Significant neurological disease (e.g. peripheral neuropathy, multiple sclerosis, stroke) or signs of neuropathy at screening
* Known bleeding disorder or anticoagulation therapy
* Planned surgery during the study period
* History of alcoholism or drug abuse in the past 2 years
* Unable to use acetaminophen
* Use of a biologic (including live vaccines, with the exception of Flumist) within the past 3 months
* Allergic reaction to a biologic or an antibody in the past
* Disqualifying laboratory values, including Hepatitis B or C, HIV or drug test
* Cancer in the past 5 years. Basal cell or squamous cell carcinoma are okay.
* Medical condition that may interfere with study endpoints or safety of the subject as determined by the investigator.
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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NEA Baptist Clinic
Jonesboro, Arkansas, United States
JDP Medical Research, LLC
Aurora, Colorado, United States
Alpine Neurology
Centennial, Colorado, United States
Peak Anesthesia
Centennial, Colorado, United States
JEM Research, LLC
Atlantis, Florida, United States
Medical Specialists of the Palm Beaches
Atlantis, Florida, United States
Bradenton Research Center, Inc
Bradenton, Florida, United States
Manatee Internal Medicine
Bradenton, Florida, United States
Clinical Physiology Associates
Fort Myers, Florida, United States
Harris Bonnette, MD
Fort Myers, Florida, United States
Sunrise Clinical Research, Inc.
Hollywood, Florida, United States
Sunrise Clinical Research, Inc
Hollywood, Florida, United States
Pharmax Research Clinic, Inc
Miami, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
The Arthritis Center
Palm Harbor, Florida, United States
Pines Neurological Associates
Pembroke Pines, Florida, United States
Pembroke Clinical Trials
Pembroke Pines, Florida, United States
Pines Neurological Associates
Pembroke Pines, Florida, United States
Advent Clinical Research Centers, Inc
Pinellas Park, Florida, United States
Advent Clinical Research Center
Pinellas Park, Florida, United States
Berma Research Group
Plantation, Florida, United States
Kennedy-White Orthopaedic Center
Sarasota, Florida, United States
Ronal Aung-Din, MD
Sarasota, Florida, United States
Ronald Aung-Din, MD
Sarasota, Florida, United States
Sarasota Center for Clinical Research
Sarasota, Florida, United States
Arthritis & Rheumatic Care Center
South Miami, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Neuroscience Consultants, LLC
South Miami, Florida, United States
Carol L. Pappas MD, PhD
St. Petersburg, Florida, United States
Carol L. Pappas, M.D. PhD
St. Petersburg, Florida, United States
Dale G. Bramlet, MD, P.L.
St. Petersburg, Florida, United States
Tampa Neurology Associates
Tampa, Florida, United States
Tampa Medical Group, P.A.
Tampa, Florida, United States
Radiology Associates of Venice & Englewood
Venice, Florida, United States
Lovelace Scientific Resources, Inc
Venice, Florida, United States
Venice Arthritis Center
Venice, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Atlanta Neurology
Atlanta, Georgia, United States
Diagnostic Imaging of Atlanta
Atlanta, Georgia, United States
NeuroTrials Research, Incorporated
Atlanta, Georgia, United States
Northwest Neurology, P.C.
Austell, Georgia, United States
Atlanta Knee and Sports Medicine
Decatur, Georgia, United States
Joseph D. Weissman, MD
Decatur, Georgia, United States
Neurology Specialists of Decatur
Decatur, Georgia, United States
Southeastern Center for Clinical Trials
Decatur, Georgia, United States
Jefrey D. Lieberman, MD
Decatur, Georgia, United States
Northwestern Lake Forest Hospital Diagnostic Imaging Centers
Bannockburn, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Consultants in Neurology, Ltd.
Northbrook, Illinois, United States
Elkhart Clinic, LLC
Elkhart, Indiana, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University Hospital
Indianapolis, Indiana, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
G. Timothy Kelly, MD
Las Vegas, Nevada, United States
Clinical Neurology Specialists
Las Vegas, Nevada, United States
Neurological Associates of Long Island, P.C.
Lake Success, New York, United States
Andrew J. Porges, M.D. PC
Roslyn, New York, United States
Asheville Imaging
Asheville, North Carolina, United States
Biltmore Medical Associates
Asheville, North Carolina, United States
Clinical Study Center of Asheville, LLC
Asheville, North Carolina, United States
Asheville Neurology
Asheville, North Carolina, United States
Unifour Medical Research Associates, LLC
Hickory, North Carolina, United States
Neurology Associates, PA
Hickory, North Carolina, United States
Unifour Medical Research Associates, LLC
Hickory, North Carolina, United States
Caldwell Memorial Hospital
Lenoir, North Carolina, United States
Northstate Clinical Research
Lenoir, North Carolina, United States
Ohio Research Center
Toledo, Ohio, United States
Bend Memorial Clinic
Bend, Oregon, United States
North Star Neurology
Bend, Oregon, United States
Altoona Hospital Campus
Altoona, Pennsylvania, United States
Blair Neurologic Associates
Altoona, Pennsylvania, United States
Blair Medical Associates
Altoona, Pennsylvania, United States
Blair Orthopedic Associates, Inc.
Altoona, Pennsylvania, United States
Bon Secour Campus
Altoona, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Coastal Carolina Research Center in Goose Creek
Goose Creek, South Carolina, United States
Tidewater Neurology
Goose Creek, South Carolina, United States
AAMR Research Clinic, PA
Amarillo, Texas, United States
Amarillo Diagnostic Clinic
Amarillo, Texas, United States
Radiant Research, Inc.
Dallas, Texas, United States
Dr. Michael Vengrow
Dallas, Texas, United States
Foundation for Southwest Orthopedic Research
Houston, Texas, United States
The Neurology Center
Houston, Texas, United States
Paragon Research Center, LLC
San Antonio, Texas, United States
Baptist M&S Imaging
San Antonio, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Christine L. Truitt, MD
San Antonio, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Neurodiagnostic Laboratories of San Antonio, Inc.
San Antonio, Texas, United States
Neurodiagnostic Laboratories of San Antonio, Inc
San Antonio, Texas, United States
Radiant Research Inc.
San Antonio, Texas, United States
IntegraTrials, L.L.C
Arlington, Virginia, United States
TLC Neurology, P.L.L.C
Arlington, Virginia, United States
Virginia Hospital Center
Arlington, Virginia, United States
Hypothe Test, LLC
Roanoke, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Evergreen Neurology and Neurodiagnostics, PLLC
Everett, 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.
Brown MT, Herrmann DN, Goldstein M, Burr AM, Smith MD, West CR, Verburg KM, Dyck PJ. Nerve safety of tanezumab, a nerve growth factor inhibitor for pain treatment. J Neurol Sci. 2014 Oct 15;345(1-2):139-47. doi: 10.1016/j.jns.2014.07.028. Epub 2014 Jul 18.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NERVE SAFETY STUDY
Identifier Type: OTHER
Identifier Source: secondary_id
A4091026
Identifier Type: -
Identifier Source: org_study_id
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