- 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 diclofenac 150 mg/day and be tolerating their diclofenac regimen.
- Pain and function levels as required by the protocol at Screening and Baseline.
- Willing to discontinue all non-study pain medications throughout 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.
- History of other disease that may involve index knee or hip including inflammatory
joint diseases, chrystalline disease (gout or pseudogout), endocrinopathies, metabolic
joint diseases, lupus erythematosus, rheumatoid arthritis (RA), joint infections,
neuropathic disorders, avascular necrosis, Paget's disease or tumors.
- Fibromyalgia, regional pain caused by lumbar or cervical compression with
radiculopathy or other moderate to severe pain that may confound assessments or
self-evaluation of the pain associated with OA.
- Signs and symptoms of clinically significant cardiac disease within 6 months prior to
screening.
- Diagnosis or 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 150
micro-mol/L in men or 133 micro-mol/L in women.
- Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy
within 30 days prior to Screening.
- Known hypersensitivity to NSAIDs (eg, diclofenac), cyclooxygenase inhibitors or
paracetamol (acetaminophen).