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

Novartis

Status and phase

Completed

Phase 4

Conditions

Acute Gouty Arthritis

Treatments

Drug: Lumiracoxib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00170781

CCOX189A2426

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.