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

November 29, 2006 updated by: Novartis

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

234

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Chair: Novartis Pharma AG, Sponsor GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

November 30, 2006

Last Update Submitted That Met QC Criteria

November 29, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCOX189A2426

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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