Conditions: Osteoarthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 610
Healthy volunteers: no

Brief summary:
We will evaluate the efficacy of PN 400 and an active comparator in patients that have Osteoarthritis of the knee.

Detailed description:
3-Month study in subjects 50 years and older with osteoarthritis of the knee. Assessments Western Ontario and McMaster Universities (WOMAC) pain and function and patient global assessment scales.

Arms:
arm 1: PN400: 500 mg naproxen/20 mg esomeprazole bid arm 2: Celecoxib 200 mg arm 3: sugar pill

Interventions: intervention 1: PN 400 (VIMOVO) intervention 2: celebrex intervention 3: Placebo intervention 4: Rescue Antacid
Intervention descriptions: intervention 1: 500 mg naproxen/20 mg esomeprazole bid intervention 2: 200 mg celecoxib qd intervention 3: sugar pill bid intervention 4: Antacid Tablets

Protocol document: