A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED)
Phase 3
Completed
- Conditions
- Osteoarthritis
- Registration Number
- NCT00269191
- Lead Sponsor
- Organon and Co
- Brief Summary
This study was conducted to assess the safety and tolerability of the drug 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
- 528
Inclusion Criteria
- Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee
- Either prior NSAID or Acetaminophen users within the the ARA functional class I,II or III
- 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.
Exclusion Criteria
- No history of concurrent arthritic disease
- uncontrolled hypertension or an active cardiac condition
- No history of hepatitis, neoplastic disease, stroke or transient ischemic attack within a specified duration.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain and physical function over 12-weeks as assessed by the WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status, as well as safety over 12-weeks as assessed by adverse experiences.
- Secondary Outcome Measures
Name Time Method Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Disease Status, Stiffness, and Overall WOMAC scales as assessed over 12-weeks.