Etoricoxib in the Treatment of Osteoarthritis (MK-0663-007)
Phase 2
Completed
- Conditions
- Osteoarthritis
- Registration Number
- NCT00242489
- Lead Sponsor
- Organon and Co
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of etoricoxib in the treatment of osteoarthritis of the knee.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1167
Inclusion Criteria
- At least 40 years of age with a clinical diagnosis of Osteoarthritis (OA)of the knee for 6 months prior to study entry (ARA class I, II, or III).
- Positive therapeutic effect from prior NSAID therapy.
- Worsening of symptoms upon withdrawal of prior treatment.
- With the exception of OA, in otherwise good health
Exclusion Criteria
- Weight no more than 280 pounds (male or female).
- Recent, sustained use of gastroprotective agents.
- History of arthroscopy of the affected knee within 6 months prior to study entry.
- History of acute ligamentous or meniscal injury of the study joint within the previous 2 years.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method WOMAC Pain Subscale, Investigator Global Assessment of Disease Status, and Patient Global Assessment of Response to Therapy (not a primary endpoint in extension periods)
- Secondary Outcome Measures
Name Time Method Physical Function Subscale (WOMAC), Stiffness Subscale (WOMAC), Patient Global Assessment of Disease Status, Investigator Global Assessment of Response to Therapy , Proportion of Patients Discontinued Due to Lack of Efficacy