This study was conducted to assess the safety and tolerability of the drug and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.

Inclusion Criteria:

• Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee
• Either prior NSAID or Acetaminophen users within the the ARA functional class I,II or III
• Patients required to demonstrate a "flare" of the signs and symptoms of OA following withdrawal of NSAID treatment
• Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA.

Exclusion Criteria:

• No history of concurrent arthritic disease
• uncontrolled hypertension or an active cardiac condition
• No history of hepatitis, neoplastic disease, stroke or transient ischemic attack within a specified duration.