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This 39-week, open label study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2360 study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumiracoxib | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To assess long-term safety and tolerability in patients who were exposed in the core study for 13 weeks to either lumiracoxib, celecoxib or placebo and who will be exposed to lumiracoxib 100 mg od for an additional 39 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall OA pain intensity (Target knee) on a 0-100 mm VAS by visit | ||
| Patient's global assessment of disease activity by visit | ||
| Physician's global assessment of disease activity by visit. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85723 | United States | |||
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C473384 | lumiracoxib |
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| Brooklyn Park |
| Minnesota |
| 55430 |
| United States |
| Albuquerque | New Mexico | 87109 | United States |
| Sioux Falls | South Dakota | 57105 | United States |
| San Antonio | Texas | 78232 | United States |
| Novartis Investigative Site | Brampton | Ontario | Canada |