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

• Status: Unknown status
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MediQuest Therapeutics
• Treatments: Nitroglycerin

Criteria

Inclusion Criteria:

• clinical diagnosis of Raynaud's phenomenon as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers

• a history of at least two Raynaud's events during a typical winter day

• must be willing to apply creams to fingers

• must be willing to undergo cold temperature exposure

• must be willing and able to stop certain medications

• must be willing to use effective contraception, if applicable

Exclusion Criteria:

• had a Raynaud's attack that required hospital or clinic intervention

• has allergies to nitroglycerin or topical medication ingredients

• has a history of migraine or chronic pain

• has an unstable medical problem that could interfere with the study

• had a heart attack or uncontrolled heart problems, hypertension, or hypotension in the past 3 months

• used any investigational drug in the past 4 weeks

• has significantly abnormal laboratory tests

• had certain major surgeries in the past 6 months

• has skin lesions on certain parts of the fingers

• women who are pregnant or nursing