Clinical trial NCT02050360: "As Required" Oral Sildenafil in Raynaud's Phenomenon
Official title: Efficacy and Safety of "as Required" Sildenafil for Patients With Moderate to Severe Raynaud's Phenomenon (RP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Raynaud's Phenomenon
Keywords: Raynaud's phenomenon
Sildenafil
Systemic Sclerosis
Local cooling
Microcirculation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo.
timeFrame: 7 days
Secondary outcomes:
measure: Frequency of RP: number of RP attacks during treatment, as compared to placebo.
timeFrame: 7 days
measure: Patients' preference: comparison between the number of patients favoring a treatment to another.
timeFrame: Every 3 weeks of treatment (week 3, 6 and 9)
measure: Pain associated with RP: Mean change in the Raynaud's pain score during treatment, as compared to placebo.
timeFrame: 7 days
measure: Frequency and severity of adverse drug events during treatment, as compared to placebo
timeFrame: 7 days
measure: Microvascular reactivity: index of skin perfusion in response to local/regional cooling after a single dose of sildenafil, as compared to placebo (laboratory experiments)
timeFrame: Week 1, 2 and 3
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble
Study officials:
affiliation: INSERM CIC03 - Unité de Pharmacologie Clinique
name: Jean-Luc CRACOWSKI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roustit M, Giai J, Gaget O, Khouri C, Mouhib M, Lotito A, Blaise S, Seinturier C, Subtil F, Paris A, Cracowski C, Imbert B, Carpentier P, Vohra S, Cracowski JL. On-Demand Sildenafil as a Treatment for Raynaud Phenomenon: A Series of n-of-1 Trials. Ann Intern Med. 2018 Nov 20;169(10):694-703. doi: 10.7326/M18-0517. Epub 2018 Oct 30.