Acute Gouty Arthritis
Conditions
Keywords
Pain, acute gout, arthritis, cyclooxygenase-2 inhibitors, lumiracoxib, indomethacin
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
Interventions
DRUGLumiracoxib
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| Safety and tolerability profile | — |
| Usage of rescue medication | — |
| SF-36 and EQ-5D | — |
| Physician's assessment of erythema of study joint | — |
| Proportion of patients who discontinued treatment because of a lack of efficacy | — |
Countries
Germany, Switzerland
Outcome results
None listed