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 (50 mg Three Times a Day)”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Lumiracoxib

Primary Measures

• Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose

Secondary Measures

• 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharma AG Study Chair Sponsor GmbH  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00170781

Study ID Number: CCOX189A2426

ClinicalTrials.gov Identifier: NCT00170781

Health Authority: Germany: Federal Institute for Drugs and Medical Devices