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