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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumiracoxib | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharma AG | Sponsor GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | Nuremberg | Germany | ||||
| For Site Information, contact Novartis Pharma AG |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| C473384 | lumiracoxib |
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| 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 |
| Basel |
| CH |
| 4002 |
| Switzerland |
| D009140 | Musculoskeletal Diseases |