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

Status unconfirmed · Phase 3

Conditions studied: Raynaud Disease

In brief

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.

Key facts

Study ID

NCT00934427

Run by

MediQuest Therapeutics

People needed

100

Starts

2009-06-01

Expected to finish

2010-07-01

Last updated by the study team

2010-07-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Redwood City, California, United States
• University of Connecticut — Farmington, Connecticut, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Michigan State University — Grand Rapids, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University of Medicine and Dentistry in New Jersey — New Brunswick, New Jersey, United States
• Carolina Arthritis — Wilmington, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Toledo — Toledo, Ohio, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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