NCT00296569
Completed
Phase 2
A 4-Week, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of MK0686 in Patients With Osteoarthritis of the Knee or Hip
ConditionsOsteoarthritis
DrugsMK0686
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 150
- Primary Endpoint
- Pain relief at the knee and hip over 4 weeks of treatment as assessed by the WOMAC Pain Subscale.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Pain relief at the knee and hip over 4 weeks of treatment as assessed by the WOMAC Pain Subscale.
Time Frame: over 4 weeks of treatment
Secondary Outcomes
- Safety and tolerability over a 4-week treatment period(over a 4-week treatment period)
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