Status:
COMPLETED
Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon
Lead Sponsor:
MediQuest Therapeutics
Conditions:
Raynaud's Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 Ray...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00266669
Start Date
December 1 2005
End Date
May 1 2006
Last Update
August 8 2007
Active Locations (19)
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1
Stanford Medical School
Stanford, California, United States, 94305
2
University of Colorado at Denver and Health Sciences Center
Denver, Colorado, United States, 80204
3
University of Connecticut
Farmington, Connecticut, United States, 06030
4
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007