Osteoarthritis, Rheumatoid Arthritis
Conditions
Keywords
Osteoarthritis, Rheumatoid Arthritis, Cox-2, lumiracoxib
Brief summary
This study tested the safety, tolerability and efficacy of lumiracoxib - a COX-2 inhibitor- in patients with primary knee osteoarthritis or rheumatoid arthritis.
Interventions
DRUGLumiracoxib
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Requirement of regular NSAID therapy * With primary osteoarthritis of the target knee (by ACR Criteria) or with a diagnosis of rheumatoid arthritis (by ACR Criteria)
Exclusion criteria
* Evidence of active ulceration of the UGI tract within 6 months prior to the screening visit or history of active bleeding of the UGI tract within the previous 5 years. As well as with pyloric or duodenal obstruction or with history of gastrointestinal parasites. * History of cardiac and cerebral thrombotic/ischemic diseases and/or events * Patients taking additional NSAIDs (including COX-2 inhibitors) during the course of the study. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess safety and tolerability profile of lumiracoxib in comparison to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Demonstrate that lumiracoxib 200mg o.d. is effective in treating OA and pain due to RA with respect to overall OA/ RA pain intensity on a 0-100 mm Visual Analog Scale (VAS) after 6 weeks of treatment in comparison to baseline | — |
| Assess efficacy of lumiracoxib compared to baseline with respect to a) overall OA/ RA pain intensity b) patient's and physician's global assessment of disease activity c) patient functional status | — |
| Use of rescue medication | — |
Outcome results
None listed