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

Completed · Phase 3

Conditions studied: Raynaud's Disease, Scleroderma, Autoimmune Diseases

In brief

The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX-503) to relieve Raynaud's symptoms and increase blood flow to the fingers.

Key facts

Study ID

NCT00419419

Run by

MediQuest Therapeutics

People needed

80

Starts

2006-12-01

Last updated by the study team

2007-05-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Outpatients, 18 years to 70 years.
• Patients with a clinical diagnosis of Raynaud's phenomenon.
• Patients who are willing to discontinue current vasodilator therapies.
• Patients who agree not to use any other investigational medications or approved therapies to treat Raynaud's phenomenon and its symptoms while participating in this study.
• Negative pregnancy test in fertile women.
• Patients who are able to give written informed consent and comply with all study requirements.

You may not qualify if…

• Patients who concurrently use any nitrate medication or medications known to interact with Nitroglycerin.
• Patients who concurrently use any medication or device which might interfere with the study medication.
• Patients who have a known allergy to Nitroglycerin or common topical gel ingredients.
• Patients with a history of headaches.
• Patients who have a history of an unstable medical problem.
• Patients with cognitive or language difficulties.
• Patients who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
• Patients who participated in a study of any investigational drug within four weeks prior to Visit 1.
• Patients who have screening laboratory values which are 20% or greater of the upper or lower limit of normal.
• Patients who have had major surgery within six months of Visit 1.
• Patients with interfering skin conditions.
• Pregnant or nursing women.

Where it is running

• Standford Medical School — Stanford, California, United States
• University of Connecticut — Farmington, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• The Center for Rheumatology — Albany, New York, United States
• Duke University — Durham, North Carolina, United States
• Lund University Hospital — Lund, Sweden
• Royal National Hospital for Rheumatic Diseases — Bath, United Kingdom
• Ninewells Hospital and Medical School — Dundee, United Kingdom
• University of Leeds — Leeds, United Kingdom
• Royal Free Hospital — London, United Kingdom
• Hope Hospital — Salford, United Kingdom

Full record on ClinicalTrials.gov

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