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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis, Arthritis

In brief

The purpose of this study is to investigate the long-term analgesic efficacy and safety of tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID) therapy.

Key facts

Study ID

NCT00809354

Run by

Pfizer

People needed

2720

Starts

2009-02-12

Expected to finish

2011-01-12

Last updated by the study team

2021-06-24

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence x-ray grade equal to, or greater than, 2.
• 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.

You may not qualify if…

• Pregnant women.
• 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.

Where it is running

• 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
• Rheumatology Associates, P.C. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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