Status:
TERMINATED
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
Lead Sponsor:
Pfizer
Conditions:
Osteoarthritis
Arthritis
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
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 fro...
Detailed Description
This study was terminated on 28 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 12 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2011
Estimated Enrollment :
2720 Patients enrolled
Trial Details
Trial ID
NCT00809354
Start Date
February 12 2009
End Date
January 12 2011
Last Update
June 24 2021
Active Locations (333)
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1
Rheumatology Associates, P.C.
Birmingham, Alabama, United States, 35205
2
Radiant Research
Birmingham, Alabama, United States, 35209
3
Alliance Clinical Research
Birmingham, Alabama, United States, 35215
4
Shades Mountain Imaging
Birmingham, Alabama, United States, 35216