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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:

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

Condition or disease Intervention/treatment Phase
Acute Gouty Arthritis Drug: Lumiracoxib Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis Gout
U.S. FDA Resources

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

Secondary Outcome Measures :
  1. Safety and tolerability profile
  2. Pain intensity in the study joint over the entire treatment period
  3. Patient’s and Physician’s global assessment of response to therapy
  4. Physician’s assessment of tenderness and swelling of study joint
  5. C-reactive protein level
  6. Proportion of patients who discontinued treatment because of a lack of efficacy
  7. Usage of rescue medication
  8. SF-36 and EQ-5D
  9. Physician’s assessment of erythema of study joint

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00170781

Nuernberg, Germany
For Site Information, contact Novartis Pharma AG
Basel, CH, Switzerland, 4002
Sponsors and Collaborators
Study Chair: Novartis Pharma AG Sponsor GmbH Identifier: NCT00170781     History of Changes
Other Study ID Numbers: CCOX189A2426
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 30, 2006
Last Verified: June 2006

Keywords provided by Novartis:
Pain, acute gout, arthritis, cyclooxygenase-2 inhibitors, lumiracoxib, indomethacin

Additional relevant MeSH terms:
Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors