- 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.
- 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
- 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
- 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.