drugset / Trial / NCT01554163

Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Korean Participants With Osteoarthritis

NCT01554163

Phase 3 Completed 239 enrolled Organon and Co
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2012-03
Primary completion
2013-03
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Celecoxib Other / unclassified 200 mg Oral
Subject Etoricoxib Small molecule 30 mg Oral

Indications