Working... Menu

"As Required" Oral Sildenafil in Raynaud's Phenomenon (PROFIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02050360
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : January 18, 2016
Information provided by (Responsible Party):
University Hospital, Grenoble

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

Condition or disease Intervention/treatment Phase
Raynaud's Phenomenon Drug: Sildenafil 40 mg Drug: Sildenafil 80 mg Drug: Placebo Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of "as Required" Sildenafil for Patients With Moderate to Severe Raynaud's Phenomenon (RP)
Study Start Date : November 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: Sildenafil 80 mg
Sildenafil 80 mg
Drug: Sildenafil 80 mg
Experimental: Sildenafil 40 mg
Sildenafil 40 mg
Drug: Sildenafil 40 mg
Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo. [ Time Frame: 7 days ]
    RCS is self-reported every day and averaged over 7-day periods

Secondary Outcome Measures :
  1. Frequency of RP: number of RP attacks during treatment, as compared to placebo. [ Time Frame: 7 days ]
    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

  2. 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) ]
  3. Pain associated with RP: Mean change in the Raynaud's pain score during treatment, as compared to placebo. [ Time Frame: 7 days ]
    Pain associated with each attack is self-reported on a 10-point scale, and averaged over 7-day periods

  4. Frequency and severity of adverse drug events during treatment, as compared to placebo [ Time Frame: 7 days ]
  5. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02050360

Layout table for location information
Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble
Grenoble, France
Sponsors and Collaborators
University Hospital, Grenoble
Layout table for investigator information
Principal Investigator: Jean-Luc CRACOWSKI, MD INSERM CIC03 - Unité de Pharmacologie Clinique

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital, Grenoble Identifier: NCT02050360     History of Changes
Other Study ID Numbers: DCIC/12/26
2013-000014-38 ( EudraCT Number )
12G01 ( Other Identifier: Promotor )
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016

Keywords provided by University Hospital, Grenoble:
Raynaud's phenomenon
Systemic Sclerosis
Local cooling

Additional relevant MeSH terms:
Layout table for MeSH terms
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents