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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00170781
First received: September 9, 2005
Last updated: November 29, 2006
Last verified: June 2006

September 9, 2005
November 29, 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 ClinicalTrials.gov 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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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
234
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Switzerland
 
NCT00170781
CCOX189A2426
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Novartis
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Study Chair: Novartis Pharma AG Sponsor GmbH
Novartis
June 2006

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