A Study to Assess the Safety and Efficacy of an Investigational Drug (MK-686) in Patients With Osteoarthritis (0686-006)
Phase 2
Completed
- Conditions
- Osteoarthritis
- Registration Number
- NCT00296569
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study is being conducted to assess the safety and tolerability of MK-0686 and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee,either prior NSAID or Acetaminophen users within the ARA functional class I,II or III and with no clinically significant diseases
- Patients required to demonstrate a flare of the signs and symptoms of OA following withdrawal of NSAID treatment
- Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA
- females must be either post-menopausal or surgically sterilized
Exclusion Criteria
- No history of concurrent arthritic disease
- No history of neoplastic disease within a specified duration
- No history of disease that causes malabsorption
- Chronic use of certain medications excluded
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain relief at the knee and hip over 4 weeks of treatment as assessed by the WOMAC Pain Subscale. over 4 weeks of treatment
- Secondary Outcome Measures
Name Time Method Safety and tolerability over a 4-week treatment period over a 4-week treatment period