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

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy and safety of a topical gel formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate to severe primary Raynaud's phenomenon or patients 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

Intervention / Treatment
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* Drug: Topical organogel with nitroglycerin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Raynaud's phenomenon 2 or more Raynaud's events on a typical winter day Agree to discontinue current treatments for Raynaud's Negative pregnancy test and agree to use effective contraception during study Exclusion Criteria: Current use of nitrate medications or medications known to interact with nitroglycerin Patients who currently use medications, like calcium channel blockers, that might interfere with study medication Patients with a known allergy to nitroglycerin or common topical ingredients Patients with a history of migraine headaches Patients with a history of unstable medical problems Patients with cognitive or language difficulties that would impair completion of assessment instruments Patients with lab screening values more than 20% outside normal range Patients with non-epithelialized skin lesions, in the area where the gel is to be applied, at the time of screening Pregnant or nursing women Women of child-bearing potential who are unwilling to comply with the contraceptive requirements

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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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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Topical organogel with nitroglycerin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in Raynaud's Assessment Score comparing active to placebo |  |  | 
| Reduction of number of Raynaud's events |  |  | 
| Decrease in duration of Raynaud's events |  |  | 
| Decrease in symptoms associated with Raynaud's |  |  | 
| Assess safety: frequency and severity of adverse events associated with the study drug |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in patient's health using physician's Global Assessment and patient's Heath Assessment Questions |  |  | 
| Reduction in emergence of digital ulcers for patients with scleroderma |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Raynaud's Phenomenon, Raynaud's Disease, Scleroderma, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Other Autoimmune Disease