Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: MediQuest Therapeutics
• Treatments: Nitroglycerin

Criteria

Inclusion Criteria:

• Clinical diagnosis of Raynaud's phenomenon

• 2 or more Raynaud's events on a typical winter day

• Agree to discontinue current treatments for Raynaud's

• Negative pregnancy test and agree to use effective contraception during study

Exclusion Criteria:

• Current use of nitrate medications or medications known to interact with nitroglycerin

• Patients who currently use medications, like calcium channel blockers, that might interfere with study medication

• Patients with a known allergy to nitroglycerin or common topical ingredients

• Patients with a history of migraine headaches

• Patients with a history of unstable medical problems

• Patients with cognitive or language difficulties that would impair completion of assessment instruments

• Patients with lab screening values more than 20% outside normal range

• Patients with non-epithelialized skin lesions, in the area where the gel is to be applied, at the time of screening

• Pregnant or nursing women

• Women of child-bearing potential who are unwilling to comply with the contraceptive requirements