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Completed

NCT Number: NCT00170781

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

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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Key information

Conditions

Acute Gouty Arthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis, Nuremberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lumiracoxib

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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)

Important dates

Study start
2005
First posted
Sep 15, 2005
Registry last updated
Nov 30, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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