Status:
COMPLETED
Lab Study of MQX-503 in Treatment of Raynaud's
Lead Sponsor:
MediQuest Therapeutics
Conditions:
Raynaud Disease
Raynaud Disease Secondary to Scleroderma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine, in comparison to a placebo control, the response to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the determination of fing...
Eligibility Criteria
Inclusion
- clinical diagnosis of Raynaud's phenomenon
- outpoatients
- agree to apply gel as per protocol
- willing to discontinue current vasodilator therapy
- agree to stop other investigational medication for Raynaud's
- negative pregnancy test is fertile females
- able to give written informed consent and comply with study requirements
Exclusion
- current use of ay nitrate medication or medications that interact with nitroglycerin
- patients with a known allergy to nitroglycerin or topical gel ingredients
- patients with a history of migraine headaches
- patients with unstable medical problems
- patients with cognitive or language difficulties
- patients with screening lab values more than 20% outside of normal
- patients with open lesions at site of application
- women of child-bearing potential who are unwilling to comply with contraceptive requirements.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00253331
Start Date
November 1 2004
End Date
September 1 2005
Last Update
May 30 2007
Active Locations (2)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
2
University of Washington Medical College
Seattle, Washington, United States, 98195