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

Study Overview
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Brief Summary
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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.

Detailed Description
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The purpose of this clinical study is to determine, in a controlled fashion, the ability of a topical formulation of 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 (RP) and with moderate to severe Raynaud's Phenomenon secondary to autoimmune diseases, such as scleroderma.

Official Title
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A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon

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

Intervention / Treatment
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* Drug: Nitroglycerin
* Drug: Topical AmphiMatrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 2<br>Placebo - Topical AmphiMatrix | Drug: Topical AmphiMatrix<br>* Individual pouch applicators containing 0.5 grams of Topical AmphiMatrix. Each dose is intended for topical usage on both hands up to five minutes before an anticipated Raynaud's attack or up to 5 minutes after the beginning of an actual Raynaud's attack. Limited to four applications per day; minimum of two hours between applications.<br>|
| Active Comparator: 1<br>Topical AmphiMatrix with Nitroglycerin | Drug: Nitroglycerin<br>* Individual pouch applicators containing 0.5 grams of Topical AmphiMatrix with Nitroglycerin. Each dose contains 4.5mg of Nitroglycerin. Each dose is intended for topical usage on both hands up to five minutes before an anticipated Raynaud's attack or up to 5 minutes after the beginning of an actual Raynaud's attack. Limited to four applications per day; minimum of two hours between applications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Raynaud's Condition Score |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of adverse events. |  | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Raynaud's, Nitroglycerin, Scleroderma