- Acute gouty arthritis meeting the American College of Rheumatology (ACR) criteria for
acute arthritis of primary gout;
- Onset of pain from an acute gouty arthritis attack within 48 hours prior to
Screening/Baseline (Visit 1);
- A rating of moderate, severe, or extreme (2, 3, or 4, respectively) on the Patient's
assessment of pain intensity in the index joint (5-point scale:0-4) at
Screening/Baseline.
- Diagnosis of any other type of arthritis including those types suspected of being
infectious in origin in the index joint or presence of any acute trauma of the index
joint. Patients with osteoarthritis will be included as long as it is mild or moderate
(according to investigator's criteria) and it does not affect the index joint;
- Acute polyarticular gout involving greater than 4 joints or chronic gout.