At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, 12-Week, Randomized, Active-Comparator-Controlled, Parallel-Group, Double Blind Study in Korea to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Patients With Osteoarthritis
In Brief
A Phase 3 clinical trial evaluating Etoricoxib 30 mg and Celecoxib 200 mg for Osteoarthritis of the Knee. Completed, enrolled 239 participants.
Detailed Summary
The main purpose of this study is to establish that etoricoxib 30 mg is safe and not inferior to celecoxib 200 mg in the treatment of the signs and symptoms of osteoarthritis in Korean patients. Given that the efficacy of etoricoxib vs. placebo in the treatment of osteoarthritis has been established, and that prescription drugs, such as celecoxib, are available for the treatment of pain associated with osteoarthritis in Korea, it would be inappropriate to subject patients with a flare of osteoarthritic pain to the placebo treatment for 12 weeks, and thus the study is designed as an active-comparator study.
Study Details
Timeline
Interventions
Etoricoxib 30 mg tablet once daily for 12 weeks.
Celecoxib 200 mg once daily for 12 weeks