"As Required" Oral Sildenafil in Raynaud's Phenomenon

Raynaud's Phenomenon Clinical Trial

— PROFIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050360
• Other study ID #: DCIC/12/26
• Secondary ID: 2013-000014-3812
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 28, 2014
• Last updated: January 15, 2016
• Start date: November 2013
• Est. completion date: May 2015

Study information

• Verified date: January 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Raynaud Disease
• Raynaud's Phenomenon

Intervention

Drug:
• Sildenafil 40 mg

• Sildenafil 80 mg

• Placebo

Locations

Country	Name	City	State
France	Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Patients' preference: comparison between the number of patients favoring a treatment to another.		Every 3 weeks of treatment (week 3, 6 and 9)	No
Secondary	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	No
Secondary	Frequency and severity of adverse drug events during treatment, as compared to placebo		7 days	Yes
Secondary	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	No