NCT00504127

Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee

A Phase 3, 53 Weeks Study on Analgesic Efficacy and Safety of Naproxcinod (HCT 3012): 26-Week, Randomized, Parallel-Group, Double-Blind, Placebo (13 Weeks)- and Naproxen (26 Weeks)-Controlled, Multicenter Study of Naproxcinod (375 mg Bid and 750 mg Bid) With a 26-Week Naproxen-Controlled Safety Follow-up in Subjects With Osteoarthritis of the Knee, and a 1-week Post-treatment Safety Follow-up

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,020 (actual)
• Sponsor: NicOx · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication of signs and symptoms of osteoarthritis

Detailed description

This is a 53 week study consisting in a 26 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen. The first 26 weeks will be followed by a naproxen-controlled treatment period up to 52 weeks and a 1-week post-treatment safety follow-up.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Naproxcinod 375 mg bid	Naproxcinod 375 mg bid
DRUG	Naproxcinod 750 mg bid	Naproxcinod 750 mg bid
DRUG	Naproxen 500 mg bid	Naproxen 500 mg bid
DRUG	placebo	placebo

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-12-01
• First posted: 2007-07-19
• Last updated: 2011-06-17

Locations

73 sites across 1 country: United States