A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon

Status unconfirmed · Phase 3

Conditions studied: Raynaud's Disease, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Other Autoimmune Disease

In brief

The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX0503) to relieve Raynaud's symptoms and increase blood flow to the fingers.

Key facts

Study ID

NCT00577304

Run by

MediQuest Therapeutics

People needed

200

Starts

2007-12-01

Expected to finish

2008-03-01

Last updated by the study team

2010-02-05

Who can join

Age: 15 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Outpatients ages 15 - 70.
• Patients with a diagnosis of Raynaud's phenomenon.
• Patients who agree to apply study medication to their fingers.
• Patients who are willing to stop current topical vasodilator therapies.
• Patients who agree not to start or change dosage of current oral vasodilator therapies.
• Patients who agree not to use any nitrate therapy while participating in this study.
• Negative pregnancy test in fertile women and agreement to use effective contraception throughout the study.

You may not qualify if…

• Patients who currently use nitrate medication or medications known to interact with nitroglycerin.
• Patients who have an allergy to nitroglycerin or common topical gel ingredients.
• Patients with a history of severe headaches.
• Patients with an unstable medical problem.
• Patients with cognitive or language difficulties that would impair their ability to complete assessment of pain instruments.
• Patients who have had a recent heart attack or other uncontrolled heart condition.
• Patients who have participated in an investigational drug study within four weeks of visit one.
• Patients who have clinically significant abnormal lab values.
• Patients who have had recent major abdominal, thoracic or vascular surgery.
• Patients with interfering skin conditions.
• Pregnant or nursing women or women unwilling to comply with contraceptive requirements.

Where it is running

• Stanford University — Stanford, California, United States
• University of Colorado Health Sciences Center — Denver, Colorado, United States
• University of Connecticut — Farmington, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• University of Chicago — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston University — Boston, Massachusetts, United States
• Arthritis Education and Treatment Center, PLLC — Grand Rapids, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, 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 — Stony Brook, New York, United States
• Carolina Arthritis — Wilmington, North Carolina, United States
• University of Toledo — Toledo, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas at Houston — Houston, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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