Efficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of Gout
Phase 4
Completed
- Conditions
- Acute Gouty Arthritis
- Registration Number
- NCT00170781
- Lead Sponsor
- Novartis
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
Inclusion Criteria
- Ambulatory cooperative male or female patients of at least 18 years of age
- With an acute attack of gout in 4 joints or less, diagnosed clinically according to the ACR 1977 classification criteria and with an onset within the last 48 hours prior to evaluation. Where more than one joint is involved, the most affected joint should be identified, as the study joint, at baseline and followed throughout the study
- Who present at Baseline with an acute pain intensity of at least moderate.
Exclusion Criteria
- With an acute attack of gout before the last 48 hours prior to evaluation
- With polyarticular gout involving > 4 joints
- With rheumatoid arthritis, infectious arthritis, pseudo-gout or other acute inflammatory arthritides.
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Novartis
🇩🇪Nuernberg, Germany
For Site Information, contact Novartis Pharma AG
🇨🇭Basel, CH, Switzerland
Novartis🇩🇪Nuernberg, Germany