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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02050360
First Posted: January 30, 2014
Last Update Posted: January 18, 2016
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.
Information provided by (Responsible Party):
University Hospital, Grenoble
  Purpose
The purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of Raynaud's phenomenon.

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

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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:
  • 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

  • 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. [ Time Frame: 7 days ]
    Pain associated with each attack is self-reported on a 10-point scale, and averaged over 7-day periods

  • 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 ]

Enrollment: 41
Study Start Date: November 2013
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
placebo
Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02050360


Locations
France
Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble
Grenoble, France
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Luc CRACOWSKI, MD INSERM CIC03 - Unité de Pharmacologie Clinique
  More Information

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02050360     History of Changes
Other Study ID Numbers: DCIC/12/26
2013-000014-38 ( EudraCT Number )
12G01 ( Other Identifier: Promotor )
First Submitted: January 28, 2014
First Posted: January 30, 2014
Last Update Posted: January 18, 2016
Last Verified: January 2016

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

Additional relevant 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