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This study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumiracoxib | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13. | ||
| Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13. | ||
| Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8. | ||
| Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8. | ||
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals Corporation | East Hanover | New Jersey | 07936 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17266764 | Derived | Dougados M, Moore A, Yu S, Gitton X. Evaluation of the patient acceptable symptom state in a pooled analysis of two multicentre, randomised, double-blind, placebo-controlled studies evaluating lumiracoxib and celecoxib in patients with osteoarthritis. Arthritis Res Ther. 2007;9(1):R11. doi: 10.1186/ar2118. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| 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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| Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13. |
| Patient's health status using the Short Form-36 (SF-36), at week 13. |
| Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8. |