Efficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of Gout

Study Overview
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Brief Summary
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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

Official Title
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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 (50 mg Three Times a Day)

Conditions
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Acute Gouty Arthritis

Intervention / Treatment
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* Drug: Lumiracoxib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lumiracoxib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, acute gout, arthritis, cyclooxygenase-2 inhibitors, lumiracoxib, indomethacin