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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
History of Changes
  Purpose

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 Intervention Phase
Acute Gouty Arthritis
 Drug: Lumiracoxib
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:

MedlinePlus related topics: Gout
U.S. FDA Resources

Further study details as provided by Novartis:

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

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

Estimated Enrollment: 234
Study Start Date: June 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170781

Locations
Germany
Novartis
Nuernberg, Germany
Switzerland
For Site Information, contact Novartis Pharma AG
Basel, CH, Switzerland, 4002
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharma AG Sponsor GmbH
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00170781     History of Changes
Other Study ID Numbers: CCOX189A2426
Study First Received: September 9, 2005
Last Updated: November 29, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on May 22, 2013