Clinical Trial: Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Study of a Topical Formulation of Nitroglycerin, Vascana® (MQX-503), and Matching Vehicle in the Treatment and Prevention of Symptoms Associated With Raynaud's Phenomenon

Brief Summary: The purpose of this study is to determine if Vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with Raynaud's Phenomenon.

Detailed Summary: Raynaud's Phenomenon is a sometimes debilitating condition in which blood flow to the fingers or toes is compromised when a patient is exposed to cold or stress. Current therapies for Raynaud's are suboptimal because they are associated with significant side effects. In this study, patient responses to cold temperature exposures in a climate-controlled room after application of the study medication are measured.
Sponsor: MediQuest Therapeutics

Current Primary Outcome: Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling) [ Time Frame: 2 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling) [ Time Frame: 2 weeks ]
  • Changes from baseline in duration of Raynaud's attacks [ Time Frame: 2 weeks ]
  • Changes from baseline in number of Raynaud's attacks [ Time Frame: 2 weeks ]
  • Changes from baseline in the Raynaud's Condition Score [ Time Frame: 2 weeks ]
  • Changes in the maximum reduction in skin temperature [ Time Frame: 2 weeks ]
  • Changes from baseline in overall disease severity measures [ Time Frame: 2 weeks ]
  • Changes in the time to return to baseline skin temperature [ Time Frame: 2 weeks ]


Original Secondary Outcome: Same as current

Information By: MediQuest Therapeutics

Dates:
Date Received: June 26, 2009
Date Started: June 2009
Date Completion: July 2010
Last Updated: July 19, 2010
Last Verified: July 2010