Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip
NCT ID: NCT00809354
Last Updated: 2021-06-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
2720 participants
INTERVENTIONAL
2009-02-12
2011-01-12
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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IV Placebo + NSAID
Oral NSAID
NSAID
IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
Tanezumab 5 mg
IV tanezumab 5 mg every 8 weeks (through Week 48)
tanezumab
IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56
Tanezumab 10 mg
IV tanezumab 10 mg every 8 weeks (through Week 48)
tanezumab
IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56
Tanezumab 5 mg + NSAID
IV doses of tanezumab 5 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
tanezumab
IV tanezumab 5 mg every 8 weeks (through Week 48)
NSAID
Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
Tanezumab 10 mg + NSAID
IV doses of tanezumab 10 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
tanezumab
IV tanezumab 10 mg every 8 weeks (through Week 48)
NSAID
Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
Interventions
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NSAID
IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
tanezumab
IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56
tanezumab
IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56
tanezumab
IV tanezumab 5 mg every 8 weeks (through Week 48)
NSAID
Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
tanezumab
IV tanezumab 10 mg every 8 weeks (through Week 48)
NSAID
Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
Eligibility Criteria
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Inclusion Criteria
* Patients must be experiencing some benefit from their current stable dose regimen of oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either 100 mg BID or 200 mg QD) and be tolerating their NSAID regimen.
* Pain level and function levels as required by the protocol at Screening and Baseline.
* Willing to discontinue all non-study pain medications for osteoarthritis except rescue medication (acetaminophen) and not use prohibited pain medications throughout the duration of the study except as permitted per protocol.
* Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion Criteria
* BMI greater than 39.
* Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to sever pain that may confound assessments or self-evaluation of the pain associated with OA.
* Signs and symptoms of clinically significant cardiac disease with 6 months prior to screening.
* Diagnosis of TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities.
* History, diagnosis, signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder.
* At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 1.7 mg/dL (men) or 1.5 mg/dL (women).
* Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening.
* Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors.
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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Rheumatology Associates, P.C.
Birmingham, Alabama, United States
Radiant Research
Birmingham, Alabama, United States
Alliance Clinical Research
Birmingham, Alabama, United States
Shades Mountain Imaging
Birmingham, Alabama, United States
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States
Saadat Ansari, MD Office
Huntsville, Alabama, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Office of Vaughn H. Mancha, Jr., MD
Montgomery, Alabama, United States
Radiant Research - Phoenix Southeast
Chandler, Arizona, United States
Dedicated Clinical Research
Goodyear, Arizona, United States
Eclipse Clinical Research
Green Valley, Arizona, United States
Midwest Internal Medicine, PLLC
Lake Havasu City, Arizona, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Mesa, Arizona, United States
Pivotal Research Centers
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
Paradise Valley, Arizona, United States
Pivotal Research Centers
Peoria, Arizona, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Phoenix, Arizona, United States
Cochise Clinical Research
Sierra Vista, Arizona, United States
Premiere Phamaceutical Research, LLC
Tempe, Arizona, United States
Radiant Research
Tucson, Arizona, United States
Arizona Research Associates
Tucson, Arizona, United States
Quality of Life Medical and Research Center
Tucson, Arizona, United States
Tucson Orthopaedic Institute
Tucson, Arizona, United States
Little Rock Diagnostic Clinic, PA
Little Rock, Arkansas, United States
Little Rock Family Practice Clinic
Little Rock, Arkansas, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Orange County Clinical Trials, Inc.
Anaheim, California, United States
Med Center
Carmichael, California, United States
eStudySite
Chula Vista, California, United States
Med Investigations, Inc.
Fair Oaks, California, United States
Triwest Research
La Mesa, California, United States
Lakewood Orthopedic Medical & Surgical Group
Lakewood, California, United States
Premier Clinical Research LLC.
Lakewood, California, United States
Prohealth Partners
Long Beach, California, United States
Peak Health Medical Group, Inc.
Los Angeles, California, United States
Synergy Clinical Research Center
National City, California, United States
eStudySite
Oceanside, California, United States
Desert Medical Group Inc., Desert Oasis Healthcare
Palm Springs, California, United States
Advances in Medicine
Rancho Mirage, California, United States
Mercy Imaging Center
Sacramento, California, United States
Northern Clinical Research
Sacramento, California, United States
California Research Foundation
San Diego, California, United States
San Diego Arthritis Medical Clinic
San Diego, California, United States
Kaiser Permanente Medical Center
San Francisco, California, United States
eStudySite
San Jose, California, United States
Trinity Clinical Trials
Santa Ana, California, United States
Apex Research Institute
Santa Ana, California, United States
St. Joseph Medical Associates
Stockton, California, United States
Westlake Medical Center
Westlake Village, California, United States
Colorado Springs Family Practice
Colorado Springs, Colorado, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States
Colorado Arthritis Center, PC
Englewood, Colorado, United States
Joao MA Nascimento, MD
Bridgeport, Connecticut, United States
New England Research Associates, LLC
Trumbull, Connecticut, United States
Rheumatology Consultants of Delaware/Delaware Arthritis
Lewes, Delaware, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States
International Physicans Research
Aventura, Florida, United States
Surgery Center of Aventura
Aventura, Florida, United States
HeartCare
Bradenton, Florida, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Nature Coast Clinical Research
Crystal River, Florida, United States
Homestead Clinical Research Group, P.A.
Cutler Bay, Florida, United States
Covance CRU, Inc.
Daytona Beach, Florida, United States
Robert W. Levin MD
Dunedin, Florida, United States
Internal Medicine Associates
Fort Myers, Florida, United States
Clinical Physiology Associates, Clinical Study Center
Fort Myers, Florida, United States
Research Consultants Group
Hialeah, Florida, United States
Palm Springs Research Institute
Hialeah, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Florida Arthritis
Lake Mary, Florida, United States
Pharmax Research Clinic, Inc.
Miami, Florida, United States
Community Research Foundation
Miami, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
Jeffrey Alper MD Research
Naples, Florida, United States
American Family Medicine
Ocala, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Sunshine Research Center
Opa-locka, Florida, United States
Arthritis Associates
Orlando, Florida, United States
Arthritis Research of Florida, Inc.
Palm Harbor, Florida, United States
University Clinical Research
Pembroke Pines, Florida, United States
Pembroke Clinical Trials
Pemkbroke Pines, Florida, United States
Advent Clinical Research Center Inc
Pinellas Park, Florida, United States
Advent Clinical Research Centers
Pinellas Park, Florida, United States
Berma Research Group
Plantation, Florida, United States
Accord Clinical Research, LLC
Port Orange, Florida, United States
HeartCare Research
Sarasota, Florida, United States
Kennedy-White Orthopaedic Center
Sarasota, Florida, United States
Sarasota Center for Clinical Research
Sarasota, Florida, United States
Lovelace Scientific Resources
Sarasota, Florida, United States
The Arthritis Specialty Centre
Sarasota, Florida, United States
Dale G. Bramlet, MD, P.L.
St. Petersburg, Florida, United States
Soutwest Florida Clinical Research Center
Tampa, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Tampa Medical Group, PA
Tampa, Florida, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, United States
Perimeter Institute for Clinical Reseach, Inc.
Atlanta, Georgia, United States
Laureate Clinical Research Group
Atlanta, Georgia, United States
ACCR/Internal Medicine
Roswell, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Institute of Arthritis Research
Idaho Falls, Idaho, United States
Idaho Arthritis & Osteoporosis Center, PC
Meridian, Idaho, United States
Saltzer Medical Group PA
Nampa, Idaho, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Rockford Orthopedic Associates
Rockford, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Springfield Clinical Research Department
Springfield, Illinois, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, United States
American Health Network of Indiana, LLC
Avon, Indiana, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Integrated Clinical Trial Services, Inc
West Des Moines, Iowa, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Center for Arthritis and Osteoporosis
Elizabethtown, Kentucky, United States
Pain Treatment Center of the Bluegrass
Lexington, Kentucky, United States
Pasadena Pharmacy
Lexington, Kentucky, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States
Multicare Specialists
Madisonville, Kentucky, United States
Gulf Coast Research, LLC
Baton Rouge, Louisiana, United States
The Bone and Joint Clinic
Baton Rouge, Louisiana, United States
MD Medical Research
Oxon Hill, Maryland, United States
Beacon Clinical Research
Brockton, Massachusetts, United States
Berkshire Rheumatology
Pittsfield, Massachusetts, United States
MedVadis Research Corporation
Watertown, Massachusetts, United States
Quest Research Institute
Bingham Farms, Michigan, United States
Rheumatology PC
Kalamazoo, Michigan, United States
Justus J Fiechtner, MD
Lansing, Michigan, United States
PCM Medical Services
Lansing, Michigan, United States
Medical Research Associates
Traverse City, Michigan, United States
The Center for Clinical Trials
Biloxi, Mississippi, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Highland Community Hospital
Picayune, Mississippi, United States
Mississippi Medical Research
Picayune, Mississippi, United States
No. County Internal Medicine & Rheumatology
Florissant, Missouri, United States
Dynamic Clinical Research, Inc.
Kansas City, Missouri, United States
Joan Prouty Moore
Kansas City, Missouri, United States
Orthopaedic & Occupational Medicine
Kansas City, Missouri, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, United States
Rheumatology and Internal Medicine Associates of West County, P.C.
St Louis, Missouri, United States
A & A Pain Institute
St Louis, Missouri, United States
Arthritis Consultants Inc.
St Louis, Missouri, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
Westroads Medical Group
Omaha, Nebraska, United States
Anderson and Collins Clinical Research Inc.
Edison, New Jersey, United States
Central Jersey Medical Research Center
Elizabeth, New Jersey, United States
Arthritis & Osteoporosis Associates, P.A.
Freehold, New Jersey, United States
Mark Fisher, MD, FACRUC
Haddon Heights, New Jersey, United States
New Jersey Physicians, LLC
Passaic, New Jersey, United States
Rheumatology Associates of North Jersey
Teaneck, New Jersey, United States
Arthritis & Osteoporosis Associates
Toms River, New Jersey, United States
Premier Research
Trenton, New Jersey, United States
Arthritis, Rheumatic & Back Disease Associates
Voorhees Township, New Jersey, United States
The Center for Rheumatology, LLP
Albany, New York, United States
Arthritis and Osteoporosis Associates of Brooklyn Heights
Brooklyn, New York, United States
NYU Hospital for Joint Diseases
New York, New York, United States
Prem C. Chatpar, MD, LLC
Plainview, New York, United States
SPRI Bronx LLC
The Bronx, New York, United States
Southgate Medical Group
West Seneca, New York, United States
Physicians East P. A.
Greenville, North Carolina, United States
Physicians East, PA
Greenville, North Carolina, United States
Clinical Trials of America, Inc
Hickory, North Carolina, United States
Piedmont Rheumatology
Hickory, North Carolina, United States
Peters Medical Research
High Point, North Carolina, United States
Wake Internal Medicine Consultants Inc
Raleigh, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Crescent Medical Research
Salisbury, North Carolina, United States
Internal Medicine Associates
Fargo, North Dakota, United States
Lillestol Research, LLC
Fargo, North Dakota, United States
Daystar Clinical Research, Inc.
Akron, Ohio, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Doctor's Urgent Care Offices
Cincinnati, Ohio, United States
Sterling Research Group
Cincinnati, Ohio, United States
Columbus Clinical Research, Inc.
Columbus, Ohio, United States
Optimed Research, LTD
Columbus, Ohio, United States
STAT Research, Inc.
Dayton, Ohio, United States
Dayton Science Institute (DSI)
Dayton, Ohio, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
PHP - Center for Clinical Research
Dayton, Ohio, United States
David R. Mandel, MD, Inc
Mayfield, Ohio, United States
Southwest Rheumatology and Research Group, LLC
Middleburg Heights, Ohio, United States
Integris Family Care of Norman
Norman, Oklahoma, United States
LION Research
Norman, Oklahoma, United States
Central Sooner Research
Norman, Oklahoma, United States
Elise Wiesner, MD
Norman, Oklahoma, United States
McBride Clinic, Inc
Norman, Oklahoma, United States
McBride Clinic
Norman, Oklahoma, United States
McBride Clinic, Inc
Oklahoma City, Oklahoma, United States
Bone and Joint Hospital at St. Anthony
Oklahoma City, Oklahoma, United States
Christine Codding, MD
Oklahoma City, Oklahoma, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Mc Bride Clinic
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Associated Orthopedics, Inc.
Oklahoma City, Oklahoma, United States
Hillcrest Clinical Research
Oklahoma City, Oklahoma, United States
Rheumatology Associates Inc
Tulsa, Oklahoma, United States
Aquilo Clinical Research
Yukon, Oklahoma, United States
Bend Memorial Clinic
Bend, Oregon, United States
Bend Memorial Clinic
Bend, Oregon, United States
Blair Orthopedics Associates
Altoona, Pennsylvania, United States
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
The Family Healthcare Center, PA
Clinton, South Carolina, United States
Columbia Arthritis Center P.A.
Columbia, South Carolina, United States
Southern Orthopaedic Sports Medicine
Columbia, South Carolina, United States
Radiant Research Inc
Greer, South Carolina, United States
The Carolina Center for Rheumatology and Arthritis Care, PA
Rock Hill, South Carolina, United States
Regional Health Clinical Research
Rapid City, South Dakota, United States
Regional Medical Clinical-Rheumatology
Rapid City, South Dakota, United States
Arthritis Clinic
Jackson, Tennessee, United States
Ramesh C. Gupta, M.D.
Memphis, Tennessee, United States
Abilene Arthritis Center
Abilene, Texas, United States
Tekton Research, Inc.
Austin, Texas, United States
Dr. Paul K. Pickrell (Physician's Office)
Austin, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
One Step Diagnostic
Houston, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Miracle Medical Center
Houston, Texas, United States
DM Clinical Research
Houston, Texas, United States
Gill Orthopedic Center
Lubbock, Texas, United States
Robert R. King, M.D.
Lubbock, Texas, United States
Southwest Rheumatology, PA
Mesquite, Texas, United States
Hill Country Medical Associates
New Braunfels, Texas, United States
Neurology Clinic of Central Texas
New Braunfels, Texas, United States
Philip Blum
Pasadena, Texas, United States
Pearland Primary Care Associates
Pearland, Texas, United States
Southwest Clinical Research Centers, LLC
Pearland, Texas, United States
Plano Primary Care Clinic
Plano, Texas, United States
Advanced Family Medical Care
Plano, Texas, United States
Alamo Clinical Research Associates
San Antonio, Texas, United States
Alamo Clinical Research Consultants
San Antonio, Texas, United States
Texas Arthritis Research Center, PA
San Antonio, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Innovative Clinical Trials
San Antonio, Texas, United States
Radiant Research San Antonio
San Antonio, Texas, United States
SAM Clinical Research Center
San Antonio, Texas, United States
San Antonio Preventive & Diagnostic Medicine, PA
San Antonio, Texas, United States
South Texas Radiology Imaging Center
San Antonio, Texas, United States
The Rehab Group
San Antonio, Texas, United States
Sugar Land Med-Ped, PA
Sugar Land, Texas, United States
Scott & White Healthcare
Temple, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
Pivotal Research Centers
Midvale, Utah, United States
Optimum Clinical Research, Inc.
Salt Lake City, Utah, United States
Radiant Research, Inc.
Salt Lake City, Utah, United States
Doris M. Rice, M.D., F.A.C.R.
Portsmouth, Virginia, United States
National Clinical Research Richmond Inc.
Richmond, Virginia, United States
Hypothe Test, LLC
Roanoke, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Tacoma Center for Arthritis Research, PS
Tacoma, Washington, United States
Gundersen Clinic Ltd.
Onalaska, Wisconsin, United States
Office of Diane Wilson
Lunenburg, Nova Scotia, Canada
MAC Research Inc.
Hamilton, Ontario, Canada
KW Musculoskeletal Research Inc.
Kitchener, Ontario, Canada
The Arthritis Program Research Group
Newmarket, Ontario, Canada
SKDS Research Inc.
Newmarket, Ontario, Canada
Dr. Saeed Shaikh
St. Catharines, Ontario, Canada
Dr. Anil Gupta
Toronto, Ontario, Canada
Groupe de Recherche en Rhumatologie et Maladies Osseuses
Québec, Quebec, Canada
Clinique Medicale St-Louis
Québec, Quebec, Canada
Polyclinique St. Eustache
Saint-Eustache, Quebec, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Centre de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, Canada
Hospital Pablo Tobon Uribe
Medellín, Antioquia, Colombia
Centro Integral de Reumatologia e Inmunologia CIREI
Bogota, Cundinamarca, Colombia
Riesgo de Fractura S.A.
Bogota-Cundinamarca, , Colombia
Clinica Las Americas
Medellín, , Colombia
Reumatologya S.A.
Medellín, , Colombia
Krishna Institute of Medical Sciences Ltd., Department of Rheumatology
Secunderabad, Andhra Pradesh, India
St. Johns Medical College Hospital, Department of Orthopaedics
Bangalore, Karnataka, India
M.S. Ramaiah Memorial Hospital, Department of Orthopaedics
Bangalore, Karnataka, India
ChanRe Rheumatology & Immunology Center & Research
Bangalore, Karnataka, India
KMC Hospital, Department of Orthopaedics
Mangalore, Karnataka, India
Sancheti Hospital
Pune, Maharashtra, India
PSG Institute of Medical Sciences and Research
Coimbatore, Tamil Nadu, India
CSM Medical University, Department of Rheumatology
Lucknow, Uttar Pradesh, India
URHIA(Unidad de Investigacion en Reumatologia)Hospital Civil de Guadalajara"Fray Antonio Alcalde"
Guadalajara, Jalisco, Mexico
Unidad de Enfermedades Reumaticas y Cronico Degenerativas S.C.
Coahuila, , Mexico
Hospital General de Culiacan, S.S., "Dr. Bernardo Gastelum".
Culiacan Sinaloa, , Mexico
Hospital Aranda de la Parra
Leon Gto, , Mexico
Beneficencia Espanola de la Laguna
Torreon Coahuila, , Mexico
READE
Amsterdam, , Netherlands
UMC St. Radboud
Nijmegen, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Cebu Orthopedic Institute
Cebu City, , Philippines
Chong Hua Hospital, Medical Arts Center
Cebu City, , Philippines
Diaz Building
Cebu City, , Philippines
Asian Hospital and Medical Center
City of Muntinlupa, , Philippines
Davao Doctors Hospital, Medical Tower
Davao City, , Philippines
Davao Doctors Hospital
Davao City, , Philippines
Rayuma Clinic, OPD , Jose Reyes Memorial Medical Center
Manila, , Philippines
Chinese General Hospital and Medical Center, Out Patient Department
Manila, , Philippines
State Healthcare Institution Moscow City Clinical Hospital #4
Moscow, , Russia
State Healthcare Institution: Moscow City Clinical Hospital #7
Moscow, , Russia
Institution Of Russian Academy of Medical Sciences
Moscow, , Russia
Federal State Healthcare Institution Clinical Hospital #122 n.a.Sokolov
Saint Petersburg, , Russia
Saint-Petersburg State Healthcare Institution "City Hospital #26"
Saint Petersburg, , Russia
Saint Petersburg State Medical University named after Pavlov
Saint Petersburg, , Russia
136 Panorama Medical Center
Panorama, CAPE TOWN, South Africa
Phelang Private Hospital Research Unit
Mamelodi East, Pretoria, South Africa
Tiervlei Trial Center
Bellville, , South Africa
Worthwhile Clinical Trials
Benoni, , South Africa
Josha Research
Bloemfontein, , South Africa
Vincent Pallotti Hospital
Cape Town, , South Africa
Private Practice
Durban, , South Africa
Randles Road Medical Center
Durban, , South Africa
A. Briel
Durbanville, , South Africa
Origin Clinical Research
Johannesburg, , South Africa
Clinresco Centres (Pty) Ltd
Kempton Park, , South Africa
Paarl Research Center
Paarl, , South Africa
TREAD Research
Parrowvalley, , South Africa
Clinical Research Unit
Pretoria, , South Africa
Kyungpook National University Hospital
Daegu, , South Korea
Inha University Hospital
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hanyang University Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, , South Korea
Corporacio Sanitaria Parc Tauli de Sabadell, Servicio de Reumatologia
Sabadell, Barcelona, Spain
Hospital El Tomillar
Dos Hermanas, Sevilla, Spain
Complejo Hospitalario Universitario de A Coruna
A Coruña, , Spain
Hospital de Cruces, Servicio de Reumatologia
Barakaldo (Vizcaya), , Spain
Clinica CIMA
Barcelona, , Spain
Servicio de Reumatologia,Institut Ferran de Reumatologia-Clinica CIMA
Barcelona, , Spain
Hospital Universitario La Paz, Servicio de Reumatologia
Madrid, , Spain
Hospital Nuestra Senora de la Esperanza, Servicio de Reumatologia
Santiago de Compostela, A Coruna, , Spain
Hospital Nuestra Senora de Valme, Servicio de Reumatologia
Seville, , Spain
Chernivtsi Regional Clinical Hospital
Chernivtsi, , Ukraine
City Clinical Hospital #5
Donetsk, , Ukraine
V.K. Gusak Institute of Urgent and Recovery Surgery
Donetsk, , Ukraine
Kiev City Oleksandrivska Clinical Hospital
Kiev, , Ukraine
Kiev City Clinical Hospital #3
Kiev, , Ukraine
State Institution "Research Centre for Radiation Medicine AMS of Ukraine"
Kiev, , Ukraine
State Institution "Institute of Gerontology AMS of Ukraine"
Kiev, , Ukraine
Municipal institution :Zaporizhzhya Regional Clinical Hospital
Zaporizhzhya, , Ukraine
Countries
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References
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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.
Schnitzer TJ, Ekman EF, Spierings EL, Greenberg HS, Smith MD, Brown MT, West CR, Verburg KM. Efficacy and safety of tanezumab monotherapy or combined with non-steroidal anti-inflammatory drugs in the treatment of knee or hip osteoarthritis pain. Ann Rheum Dis. 2015 Jun;74(6):1202-11. doi: 10.1136/annrheumdis-2013-204905. Epub 2014 Mar 13.
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Other Identifiers
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2008-004815-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OA CONTROLLED SAFETY STUDY
Identifier Type: OTHER
Identifier Source: secondary_id
A4091025
Identifier Type: -
Identifier Source: org_study_id
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