An Investigational Drug in Patients With Osteoarthritis (0663-073)
This study was conducted to assess the safety and tolerability of an investigational drug and to evaluate its effectiveness in the treatment of osteoarthritis of the hip or knee in both men and women.
Drug: MK0663, etoricoxib
Drug: Comparators: ibuprofen and placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A 12-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Ibuprofen 2400 mg in Patients With Osteoarthritis (Study 2)|
- WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status Scale. Efficacy data collected at Weeks 2, 4, 8, and 12.
- Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Disease Status, Womac VA 3.0: Stiffness, Overall Average Score and Overall Subscale Average. Clinical efficacy data collected at Weeks 2, 4, 8, and 12.
|Study Start Date:||April 2003|
|Study Completion Date:||November 2003|
|Primary Completion Date:||November 2003 (Final data collection date for primary outcome measure)|
The duration of treatment is 12 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092755
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|