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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 9, 2005

Last Updated Date

November 29, 2006

Start Date ^†

June 2005

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00170781 on ClinicalTrials.gov Archive Site

Current Secondary Outcome 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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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)

Brief 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

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Acute Gouty Arthritis

Intervention ^†

Drug: Lumiracoxib

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

234

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany, Switzerland

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00170781

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Chair:

Novartis Pharma AG

Sponsor GmbH

Information Provided By

Novartis

Verification Date

June 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.