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

This study is currently recruiting participants. (see Contacts and Locations)
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
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, see Learn About Clinical Studies.

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
Urological Agents

ClinicalTrials.gov processed this record on August 26, 2014