Status:
COMPLETED
Efficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of Gout
Lead Sponsor:
Novartis
Conditions:
Acute Gouty Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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, para...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT00170781
Start Date
June 1 2005
Last Update
November 30 2006
Active Locations (2)
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1
Novartis
Nuremberg, Germany
2
For Site Information, contact Novartis Pharma AG
Basel, CH, Switzerland, 4002