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

Acute Gouty Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170781
• Other study ID #: CCOX189A2426
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: November 29, 2006
• Start date: June 2005

Study information

• Verified date: June 2006
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Gouty Arthritis
• Arthritis, Gouty

Intervention

Drug:
• Lumiracoxib

Locations

Country	Name	City	State
Germany	Novartis	Nuernberg
Switzerland	For Site Information, contact Novartis Pharma AG	Basel	CH

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose
Secondary	Safety and tolerability profile
Secondary	Pain intensity in the study joint over the entire treatment period
Secondary	Patient’s and Physician’s global assessment of response to therapy
Secondary	Physician’s assessment of tenderness and swelling of study joint
Secondary	C-reactive protein level
Secondary	Proportion of patients who discontinued treatment because of a lack of efficacy
Secondary	Usage of rescue medication
Secondary	SF-36 and EQ-5D
Secondary	Physician’s assessment of erythema of study joint