NCT00665431

Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis

Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Center Study Evaluating the Efficacy of PN400 (VIMOVO) Twice Daily (Bid) and Celecoxib Once Daily (qd) in Patients With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 610 (actual)
• Sponsor: POZEN · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	PN 400 (VIMOVO)	500 mg naproxen/20 mg esomeprazole bid
DRUG	celebrex	200 mg celecoxib qd
OTHER	Placebo	sugar pill bid
DRUG	Rescue Antacid	Antacid Tablets

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2008-04-23
• Last updated: 2011-12-06
• Results posted: 2011-12-06

Locations

1 site across 1 country: United States