"As Required" Oral Sildenafil in Raynaud's Phenomenon

Phase 3CompletedNCT02050360

University Hospital, Grenoble41 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Raynaud's Phenomenon

Interventions

Sildenafil 40 mgDRUG

Sildenafil 80 mgDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble

Grenoble, France

Outcomes

Primary Outcomes

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

Time frame: 7 days

Secondary Outcomes

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

Time frame: 7 days

Patients' preference: comparison between the number of patients favoring a treatment to another.

Time frame: 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

Time frame: 7 days

Frequency and severity of adverse drug events during treatment, as compared to placebo

Time frame: 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)

Time frame: Week 1, 2 and 3

Data from ClinicalTrials.gov

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