Clinical Trial: Efficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of Gout
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A 1-Week, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Parallel Trial Comparing Lumiracoxib (400 mg Once Daily) in Patients With Acute Flares of Gout, Using Indomethacin (5
Brief Summary: This study is designed to develop our understanding of the efficacy and safety of using lumiracoxib in the treatment of patients with acute gout. This is a multi-center, double-blind, randomized, parallel group study comparing a single daily dose of 400 mg lumiracoxib with the established dose of indomethacin 50 mg taken three times a day in terms of efficacy
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose
Original Primary Outcome:
Current Secondary Outcome:
- Safety and tolerability profile
- Pain intensity in the study joint over the entire treatment period
- Patient’s and Physician’s global assessment of response to therapy
- Physician’s assessment of tenderness and swelling of study joint
- C-reactive protein level
- Proportion of patients who discontinued treatment because of a lack of efficacy
- Usage of rescue medication
- SF-36 and EQ-5D
- Physician’s assessment of erythema of study joint
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: September 9, 2005
Date Started: June 2005
Date Completion:
Last Updated: November 29, 2006
Last Verified: June 2006
