Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy, tolerability, and safety of the investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip osteoarthritis. Both lumiracoxib and celecoxib belong to the same class of drug (COX-2 selective nonsteroidal anti-inflammatory drugs [NSAIDs]).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumiracoxib (drug) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC 3.1 LK questionnaire after 13 weeks of treatment | ||
| Patient's global assessment of disease activity (VAS) after 13 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall OA pain intensity (VAS)by visit | ||
| Physician's global assessment of disease activity (VAS) by visit | ||
| Response to treatment according to OARSI criteria by visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For US Site Information, contact Novartis Pharmaceuticals | East Hanover | New Jersey | 07936 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21607551 | Derived | Schnitzer TJ, Dattani ID, Seriolo B, Schneider H, Moore A, Tseng L, Sallstig P, Rebuli R, Maxwell T. A 13-week, multicenter, randomized, double-blind study of lumiracoxib in hip osteoarthritis. Clin Rheumatol. 2011 Nov;30(11):1433-46. doi: 10.1007/s10067-011-1776-4. Epub 2011 May 24. |
| Label | URL |
|---|---|
| Novartis patient recruitment website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C473384 | lumiracoxib |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Actual OA pain intensity at 12 hours post-dose by visit |
| Number of rescue tablets taken during the study |
| Various Sites |
| Multiple Cities |
| Canada |
| Various Sites | Multiple Cities | Germany |
| Various Sites | Multiple Cities | Italy |
| Various Sites | Multiple Cities | United Kingdom |