NCT00542555

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

301: A Phase 3 Study of the Analgesic Efficacy and Safety of HCT 3012: A Parallel, Randomized, Double Blind, 13 Week Placebo and Naproxen Controlled, Multicenter Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Patients With Osteoarthritis of the Knee, Followed by Its Extension (301E): A Parallel, Randomized, Open-Label, Multicenter, 52-Week Follow-up Safety Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Subjects With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 918 (actual)
• Sponsor: NicOx · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

To study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of Osteoarthritis.

Detailed description

This is a 13-week double-blind study followed by a 52-week, open-label, roll-over on active treatment study. These are randomized, parallel group, multicenter studies comparing efficacy and safety of naproxcinod, placebo and naproxen.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Placebo	At 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study.
DRUG	Naproxcinod 375 mg
DRUG	Naproxen
DRUG	Naproxcinod 750 mg

Timeline

• Start date: 2005-12-01
• Completion: 2007-09-01
• First posted: 2007-10-11
• Last updated: 2011-06-17