A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED)
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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 1)
Actual Study Start Date
February 5, 2003
Actual Primary Completion Date
November 7, 2003
Actual Study Completion Date
November 21, 2003
Resource links provided by the National Library of Medicine
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
Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Disease Status, Stiffness, and Overall WOMAC scales as assessed over 12-weeks.
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Ages Eligible for Study:
40 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.