As Required Oral Sildenafil in Raynaud's Phenomenon

Study Overview
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Brief Summary
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The purpose of this study is to determine whether on-demand sildenafil is effective in the treatment of Raynaud's phenomenon.

Official Title
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Efficacy and Safety of as Required Sildenafil for Patients With Moderate to Severe Raynaud's Phenomenon (RP)

Conditions
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Raynaud's Phenomenon

Intervention / Treatment
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* Drug: Sildenafil 40 mg
* Drug: Sildenafil 80 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active Raynaud's Phenomenon characterized by a clinical history of primary or secondary Raynaud's Phenomenon At least 7 RP attacks per week on 5 or more days per week (assessed over the 2 weeks preceding inclusion) Patients who have dated and signed the informed consent form Contraception for women Exclusion Criteria: Recently diagnosed RP (less than 2 months). Uncontrolled hypertension, diabetes mellitus, angina Haemodynamic instability Nonarteritic ischemic optic neuropathy Pulmonary hypertension Subjects currently taking sildenafil, tadalafil or vardenafil Subjects currently taking nitrates Subjects currently taking strong CYP3A inhibitors Pregnancy (or considering pregnancy in the next 4 months) Breast feeding Participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Sildenafil 80 mg<br>Sildenafil 80 mg | Drug: Sildenafil 80 mg<br> <br> |
| Experimental: Sildenafil 40 mg<br>Sildenafil 40 mg | Drug: Sildenafil 40 mg<br> <br> |
| Placebo Comparator: Placebo<br>placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo. | RCS is self-reported every day and averaged over 7-day periods | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of RP: number of RP attacks during treatment, as compared to placebo. | An attack is defined as an episode of pallor or cyanosis (with or without pain,tingling or numbness). The number of attacks is self-reported every day and averaged over 7-day periods | 7 days | 
| Patients' preference: comparison between the number of patients favoring a treatment to another. |  | Every 3 weeks of treatment (week 3, 6 and 9) | 
| Pain associated with RP: Mean change in the Raynaud's pain score during treatment, as compared to placebo. | Pain associated with each attack is self-reported on a 10-point scale, and averaged over 7-day periods | 7 days | 
| Frequency and severity of adverse drug events during treatment, as compared to placebo |  | 7 days | 
| Microvascular reactivity: index of skin perfusion in response to local/regional cooling after a single dose of sildenafil, as compared to placebo (laboratory experiments) |  | Week 1, 2 and 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Raynaud's phenomenon, Sildenafil, Systemic Sclerosis, Local cooling, Microcirculation