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

Information source: MediQuest Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Raynaud's Disease; Scleroderma; Autoimmune Diseases

Intervention: Topical AmphiMatrix with nitroglycerin (MQX-503) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: MediQuest Therapeutics


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.

Clinical Details

Official title: Phase III "In-Life" Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud's Phenomenon

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Reduction in Raynaud's Condition Score

Secondary outcome: Frequency and Severity of adverse events

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.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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.

Locations and Contacts

Lund University Hospital, Lund 221 185, Sweden

Royal National Hospital for Rheumatic Diseases, Bath LX1 3EX, United Kingdom

Ninewells Hospital and Medical School, Dundee DD1 9SY, United Kingdom

University of Leeds, Leeds LS7 4SA, United Kingdom

Royal Free Hospital, London NW3 2QH, United Kingdom

Hope Hospital, Salford M6 8HD, United Kingdom

Standford Medical School, Stanford, California 94305, United States

University of Connecticut, Farmington, Connecticut 06030, United States

Georgetown University Medical Center, Washington, District of Columbia 20007, United States

Johns Hopkins Bayview Medical Center, Baltimore, Maryland 21224, United States

The Center for Rheumatology, Albany, New York 12206, United States

Duke University, Durham, North Carolina 27710, United States

Additional Information

Starting date: December 2006
Last updated: May 29, 2007

Page last updated: August 23, 2015

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