Celebrex In Acute Gouty Arthritis Study

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, double-blind, double-dummy, randomized, active-controlled study that will include an 8-day treatment period followed by a 1-week follow-up period in patients experiencing symptoms of an acute exacerbation of gouty arthritis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Celecoxib; Indomethacin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.