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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MediQuest Therapeutics
• Treatments: Nitroglycerin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.