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

Condition(s) targeted: Acute Gouty Arthritis

Intervention: Lumiracoxib (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharma AG, Study Chair, Affiliation: Sponsor

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: 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)

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

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

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Novartis, Nuernberg, Germany

For Site Information, contact Novartis Pharma AG, Basel, CH 4002, Switzerland

Starting date: June 2005
Last updated: November 29, 2006