NCT01554163

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	Etoricoxib 30 mg	Etoricoxib 30 mg tablet once daily for 12 weeks.
DRUG	Celecoxib 200 mg	Celecoxib 200 mg once daily for 12 weeks

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-03-14
• Last updated: 2022-02-09
• Results posted: 2013-12-04