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This 39-week, active controlled, 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 CCOX189A2361 study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lumiracoxib | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To compare lumiracoxib 100mg od to celecoxib 200mg od in treating osteoarthritis (OS) of the target knee with respect to: | ||
| Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 26 weeks. | ||
| Patient's global assessment of disease activity on a 0-100mm VAS at 26 weeks. | ||
| Patient's functional status using the WOMAC total score at 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability profile of lumiracoxib as compared to celecoxib | ||
| To assess the efficacy of lumiracoxib as compared to celecoxib with respect to: | ||
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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 |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Malvern | Australia | ||||
| Novartis Investigative Site |
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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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| Overall OA pain intensity 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 |
| Patient's functional status using the WOMAC 3.1 LK sub-scale scores and total score by visit |
| Usage of rescue medication |
| Response to treatment according to OARSI criteria by visit |
| Vienna |
| Austria |
| Novartis Investigative Site | Prague | Czechia |
| Novartis Investigative Site | Turku | Finland |
| Novartis Investigative Site | Dresden | Germany |
| Novartis Investigative Site | Budapest | Hungary |
| Novartis Investigative Site | Haifa | Israel |
| Novartis Investigative Site | Lisse | Netherlands |
| Novartis Investigative Site | Rotorua | New Zealand |
| Novartis Investigative Site | Poznan | Poland |
| Novartis Investigative Site | Bratislava | Slovakia |
| Novartis Investigative Site | Johannesburg | South Africa |
| Novartis Investigative Site | Seville | Spain |
| Novartis Investigative Site | Uppsala | Sweden |
| Novartis Investigative Site | Izmir | Turkey (Türkiye) |