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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00170781
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 30, 2006
Information provided by:

September 9, 2005
September 15, 2005
November 30, 2006
June 2005
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Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose
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Complete list of historical versions of study NCT00170781 on Archive Site
  • 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
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Efficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of Gout
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
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Acute Gouty Arthritis
Drug: Lumiracoxib
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Germany,   Switzerland
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Study Chair: Novartis Pharma AG Sponsor GmbH
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP