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This trial will compare the retention on treatment (based on the rate of patients staying on treatment for 1 year) of patients suffering from primary osteoarthritis using two different doses of lumiracoxib (100 mg od or 100 mg bid) or using celecoxib (200 mg od)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumiracoxib | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To show that either regimen of lumiracoxib (100mg od or 100mg bid) is not inferior to celecoxib 200mg od with respect to retention rate at 1 year in pts suffering from primary OA in hip, knee, hand or spine. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety & tolerability of pts using lumiracoxib vs pts using celecoxib | ||
| Efficacy of lumiracoxib vs celecoxib with respect to Patient's assessment of OA pain, Patient's global assessment of disease activity, and Physician's global assessment of disease activity |
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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 | Nuremberg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18328090 | Derived | Fleischmann R, Tannenbaum H, Patel NP, Notter M, Sallstig P, Reginster JY. Long-term retention on treatment with lumiracoxib 100 mg once or twice daily compared with celecoxib 200 mg once daily: a randomised controlled trial in patients with osteoarthritis. BMC Musculoskelet Disord. 2008 Mar 7;9:32. doi: 10.1186/1471-2474-9-32. |
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| To compare reasons for discontinuation from treatment with lumiracoxib vs treatment with celecoxib |
| To validate the psychometric properties of the Short Arthritis assessment Scale (SAS) by analyzing pt reported outcomes collected in this study |
| 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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