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

This study is currently recruiting participants.
Verified January 2014 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT02050360
First received: January 28, 2014
Last updated: January 29, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • Pain associated with RP: Mean change in the Raynaud's pain score during treatment, as compared to placebo. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: November 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 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 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02050360

Contacts
Contact: Matthieu Roustit, PharmD, PhD MRoustit@chu-grenoble.fr

Locations
France
Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble Recruiting
Grenoble, France
Contact: Jean-Luc CRACOWSKI, MD, PhD       JLCracowski@chu-grenoble.fr   
Contact: Matthieu ROUSTIT, PhamD- PhD       MRoustit@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Luc CRACOWSKI, MD INSERM CIC03 - Unité de Pharmacologie Clinique
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02050360     History of Changes
Other Study ID Numbers: DCIC/12/26, 2013-000014-38, 12G01
Study First Received: January 28, 2014
Last Updated: January 29, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014