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

Phase 3

Completed

• Conditions: Raynaud's Disease; Scleroderma; Autoimmune Diseases

• Registration Number: NCT00419419
• Lead Sponsor: MediQuest Therapeutics

Brief 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.

Detailed Description

The purpose of this clinical study is to determine, in a controlled fashion, the ability of Topical AmphiMatrix formulation with Nitroglycerin (MQX-503) to improve the patient's health assessment as indicated by patient and physician assessments, decrease the frequency of Raynaud's events, decrease the duration of Raynaud's events, and decrease the symptoms (pain, tingling, numbness) in the fingers of Raynaud's patients. The study will include patients with moderate to severe primary Raynaud's phenomenon and with Raynaud's phenomenon secondary to autoimmune diseases such as scleroderma.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-04
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-08
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-29
• Last Update Posted: 2007-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Reduction in Raynaud's Condition Score

Secondary Outcome Measures

Name	Time	Method
Frequency and Severity of adverse events

Trial Locations

Locations (12)

Hope Hospital; 🇬🇧 Salford, United Kingdom

The Center for Rheumatology; 🇺🇸 Albany, New York, United States

Ninewells Hospital and Medical School; 🇬🇧 Dundee, United Kingdom

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States

Royal National Hospital for Rheumatic Diseases; 🇬🇧 Bath, United Kingdom

Standford Medical School; 🇺🇸 Stanford, California, United States

Royal Free Hospital; 🇬🇧 London, United Kingdom

Lund University Hospital; 🇸🇪 Lund, Sweden

University of Leeds; 🇬🇧 Leeds, United Kingdom

University of Connecticut; 🇺🇸 Farmington, Connecticut, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States