Phase III Study of a Topical Gel Formulation for 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 (MQX-503) 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 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.

Official Title
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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

Conditions
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Raynaud's Disease, Scleroderma, Autoimmune Diseases

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Topical AmphiMatrix with nitroglycerin (MQX-503)|nan|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and Severity of adverse events |  |  | 

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