Clinical Trial: Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase III "in-Life" Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud's Phenomenon
Brief Summary: The purpose of this study is to investigate the efficacy and safety of a topical gel formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate to severe primary Raynaud's phenomenon or patients with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma.
Detailed Summary:
Sponsor: MediQuest Therapeutics
Current Primary Outcome:
- Improvements in Raynaud's Assessment Score comparing active to placebo
- Reduction of number of Raynaud's events
- Decrease in duration of Raynaud's events
- Decrease in symptoms associated with Raynaud's
- Assess safety: frequency and severity of adverse events associated with the study drug
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Improvement in patient's health using physician's Global Assessment and patient's Heath Assessment Questions
- Reduction in emergence of digital ulcers for patients with scleroderma
Original Secondary Outcome:
- Improvement in patient's health using physician's Global Assessment and patient's Heath Assessmetn Questions
- Reduction in emergence of digital ulcers for patients with scleroderma
Information By: MediQuest Therapeutics
Dates:
Date Received: December 15, 2005
Date Started: December 2005
Date Completion: May 2006
Last Updated: August 6, 2007
Last Verified: August 2007