Clinical Trial: Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A 13-Week, Phase 3, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Bid and Naproxen 500 mg Bid, Controlled Study on the Efficacy on Signs and Symptoms, and Safety of Naproxcinod (HCT30
Brief Summary: To study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of signs and symptoms of Osteoarthritis.
Detailed Summary: This is a 13 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen.
Sponsor: NicOx
Current Primary Outcome: The primary objective of this study is to show that Naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the hip
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: NicOx
Dates:
Date Received: October 8, 2007
Date Started: June 2007
Date Completion:
Last Updated: February 19, 2009
Last Verified: February 2009