Status:
UNKNOWN
Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms
Lead Sponsor:
MediQuest Therapeutics
Conditions:
Raynaud Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 Description
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 su...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00934427
Start Date
June 1 2009
End Date
July 1 2010
Last Update
July 20 2010
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University
Redwood City, California, United States, 94063
2
University of Connecticut
Farmington, Connecticut, United States, 06030
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
University of Michigan
Ann Arbor, Michigan, United States, 48106