Osteoarthritis, Hip
Conditions
Keywords
Osteoarthritis, Hip, Lumiracoxib, Efficacy, Safety
Brief summary
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 \[NSAIDs\]).
Interventions
DRUGLumiracoxib (drug)
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary hip osteoarthritis * Qualifying pain intensity in the hip joint * Requiring NSAID therapy
Exclusion criteria
* Rheumatoid arthritis or other inflammatory joint disease * Disease or disorder that may interfere with pain assessment of the hip * Open knee/hip surgery within the last year * Past history of heart attack, stroke or angina (chest pain) * Liver disorder * History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment Other protocol-defined
Design outcomes
Primary
| Measure | 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Response to treatment according to OARSI criteria by visit | — |
| Overall OA pain intensity (VAS)by visit | — |
| Number of rescue tablets taken during the study | — |
| Actual OA pain intensity at 12 hours post-dose by visit | — |
| Physician's global assessment of disease activity (VAS) by visit | — |
Countries
Canada, Germany, Italy, United Kingdom, United States
Outcome results
None listed