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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 - NCT00809354-54650(Clinical Trial 259851)



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City:  Onalaska
State:  
WI
Zip Code: 54650
Conditions: Osteoarthritis - Arthritis
Purpose: 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.
Study summary:
Criteria: Inclusion Criteria: - 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. Exclusion Criteria: - 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.
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Data Source: ClinicalTrials.gov
Date Processed: July 2, 2010
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