Clinical Trial: Safety and Efficacy of Lumiracoxib Versus Naproxen in Acute Musculoskeletal Pain
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A 7-Day Multicenter Randomized Double-Blind, Double-Dummy Parallel Group Trial to Assess the Safety and Efficacy of 400 mg Lumiracoxib Once Daily Versus 500 mg Naproxen Twice Daily in Patients With Ac
Brief Summary: This study is designed to develop our understanding of the risk-benefit of using lumiracoxib in patients with acute musculoskeletal pain due to uncomplicated soft tissue injury.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: Decrease in sum of pain intensity difference scores over first 5 days of treatment
Original Primary Outcome:
Current Secondary Outcome:
- Decrease in sum of pain intensity difference scores over 7 days of treatment; Improvement in how pts feel about their pain; Comparable perceived pain relief; Comparable treatment satisfaction
- Safety and efficacy as compared to naproxen.
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: September 9, 2005
Date Started: November 2004
Date Completion:
Last Updated: October 12, 2006
Last Verified: June 2006
