Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
614 participants
INTERVENTIONAL
2009-10-30
2011-02-04
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
oxycodone
oxycodone CR, 10-40 mg q12h
4
placebo
placebo
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
oxycodone
oxycodone CR, 10-40 mg q12h
placebo
placebo
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
75 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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Achieve Clinical Research
Birmingham, Alabama, United States
Alabama Orthopaedic Clinics, PC
Mobile, Alabama, United States
Horizon Research Group, Inc.
Mobile, Alabama, United States
Arizona Research Center, Inc.
Phoenix, Arizona, United States
Osteoporosis Medical Center
Beverly Hills, California, United States
Med Frontier Clinical Research
Buena Park, California, United States
Providence Clinical Research
Burbank, California, United States
Valley Research
Fresno, California, United States
Apex Research Institute
Santa Ana, California, United States
Medvin Clinical Research
Van Nuys, California, United States
Advanced Radiology
Stamford, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Homestead Clinical Research Group, P.A.
Cutler Bay, Florida, United States
Riverside Clinical Research
Edgewater, Florida, United States
Florida Clinical Research Center, LLC
Fruitland Park, Florida, United States
Adult Medicine Specialists
Longwood, Florida, United States
Genesis Research International
Longwood, Florida, United States
Community Research Foundation, Inc.
Miami, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Advent Clinical Research Centers, Inc.
Pinellas Park, Florida, United States
Sarasota Center For Clinical Research
Sarasota, Florida, United States
Dale G. Bramlet, MD
St. Petersburg, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Laureate Clinical Research Group
Atlanta, Georgia, United States
Drug Studies America Inc.
Marietta, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
North Goergia Internal Medicine
Woodstock, Georgia, United States
Americana Orthopedics
Boise, Idaho, United States
Sonora Clinical Research, LLC.
Boise, Idaho, United States
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, United States
Commonwealth Biomedical Research
Madisonville, Kentucky, United States
Mid-Atlantic Medical Research
Hollywood, Maryland, United States
Miray Medical Center
Brockton, Massachusetts, United States
MedVadis Research Corporation
Watertown, Massachusetts, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Great Lakes Research Group, Incorporated
Bay City, Michigan, United States
The Center for Clinical Trials
Biloxi, Mississippi, United States
Mercy Health Research
St Louis, Missouri, United States
Midwest Minor Medical
Omaha, Nebraska, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, United States
Midwest Minor Medical
Omaha, Nebraska, United States
Midwest Minor Medical
Omaha, Nebraska, United States
Diagnostic Center of Medicine
Henderson, Nevada, United States
Office of Matthew Barton, MD
Las Vegas, Nevada, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
Office of Andrew J. Porges, MD PC
Roslyn, New York, United States
MediSpect, LLC
Boone, North Carolina, United States
Crescent Medical Research
Salisbury, North Carolina, United States
Hilltop Medical Research Center
Cincinnati, Ohio, United States
Columbus Clinical Research
Columbus, Ohio, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, United States
Piedmont Arthritis Clinic, PA
Greenville, South Carolina, United States
Health Concepts
Rapid City, South Dakota, United States
TriCities Medical Research
Bristol, Tennessee, United States
Appalachian Medical Research Inc.
Johnson City, Tennessee, United States
ClinRx Research, LLC
Carrollton, Texas, United States
Tekton Research, Inc
Georgetown, Texas, United States
One Step Diagnostic (X-Ray Facility)
Houston, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
Leander Healthcare Center
Leander, Texas, United States
ClinRx Research
Richardson, Texas, United States
Oakwell Clinical research, LLC
San Antonio, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
LKH/Universitatsklinikum Graz
Graz, , Austria
Nuhr Zentrum
Senftenberg, , Austria
ClinPharm International GmbH
Vienna, , Austria
Synexus ClinPharm GmbH
Vienna, , Austria
Rheuma Zentrum Favoriten
Vienna, , Austria
CCBR A/S
Aalborg, , Denmark
CCBR A/S
Ballerup Municipality, , Denmark
Frederiksberg Hospital Parker Institute
Frederiksberg, , Denmark
CCBR A/S
Vejle, , Denmark
Charité Universitätsmedizin Berlin
Berlin, , Germany
Klinische Forschung Berlin-Buch GmbH
Berlin, , Germany
Viereck-Apotheke
Berlin, , Germany
Charité Campus Virchow-Klinikum Apotheke
Berlin, , Germany
ClinPharm International GmbH
Bochum, , Germany
Herz Apotheke
Bochum, , Germany
Synexus ClinPharm GmbH
Bochum, , Germany
Synexus ClinPharm GmbH / Frankfurt/M
Frankfurt am Main, , Germany
Schiller-Apotheke
Göppingen, , Germany
Schmerz und Palliativ-Zentrum Goppingen
Göppingen, , Germany
Falken Apotheke Hoheluft
Hamburg, , Germany
Klinische Forschung Hamburg GmbH
Hamburg, , Germany
Klinische Forschung Hannover-Mitte GmbH
Hanover, , Germany
Löwen Apotheke
Hanover, , Germany
Synexus ClinPharm GmbH
Leipzig, , Germany
Arkana Apotheke OHG
Leipzig, , Germany
Synexus ClinPharm GmbH Pruefzentrum Magdeburg
Magdeburg, , Germany
Apotheke im MSZ
Magdeburg, , Germany
Schwanen Apotheke am Markt
Offenbach, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
Sonnenapotheke
Schwerin, , Germany
Nzoz Centrum Medyczne
Bialystok, , Poland
Szpital Specjalistyczny im. J. Dietla
Krakow, , Poland
NZOZ REUMED Sp.zo.o.
Lublin, , Poland
Medyczne Centrum Hetmanska
Poznan, , Poland
NZOZ "Nasz Lekarz"
Torun, , Poland
Centrum Medyczne OSTEOMED NZOZ
Warsaw, , Poland
Hospital Nuestra Senora de la Esperanza
Santiago de Compostela, A Coruña, Spain
Complejo Hospitalario Universitario de A Coruna
A Coruña, , Spain
Hospital Regional Universitario Carlos Haya (Hospital Civil)
Málaga, , Spain
Hospital Regional Universitario Carlos Haya (Hospital Civil)
Málaga, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Me3plus AB
Gothenburg, , Sweden
Me3plus AB
Gothenburg, , Sweden
Avdelningen for klinisk provning, Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Center for Clinical Studies
Malmo, , Sweden
Bragee Medect AB
Stockholm, , Sweden
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.
Spierings 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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2009-013329-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OA OXY STUDY
Identifier Type: OTHER
Identifier Source: secondary_id
A4091030
Identifier Type: -
Identifier Source: org_study_id
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