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

Completed · Phase 3

Conditions studied: Raynaud's Disease

In brief

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.

Key facts

Study ID

NCT00266669

Run by

MediQuest Therapeutics

People needed

200

Starts

2005-12-01

Expected to finish

2006-05-01

Last updated by the study team

2007-08-08

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
• 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

You may not qualify if…

• 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

Where it is running

• Stanford Medical School — Stanford, California, United States
• University of Colorado at Denver and Health Sciences Center — Denver, Colorado, United States
• University of Connecticut — Farmington, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• University of Chicago Center for Advanced Medicine — Chicago, Illinois, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• Arthritis Education & Treatment Center, PLLC — Grand Rapids, Michigan, United States
• University of Medicine and Dentistry of New Jersey — New Brunswick, New Jersey, United States
• The Center for Rheumatology — Albany, New York, United States
• SUNY Stony Brook — East Setauket, New York, United States
• Duke University — Durham, North Carolina, United States
• Medical University of Ohio — Toledo, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Medical School at Houston — Houston, Texas, United States
• Virginia Mason Benaroya Research Institute — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• St. Joseph's Health Care — London, Ontario, Canada
• SMBD Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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