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

January 15, 2016 updated by: University Hospital, Grenoble

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France
        • Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
placebo
Drug: Placebo
EXPERIMENTAL: Sildenafil 80 mg
Drug: Sildenafil 80 mg
EXPERIMENTAL: Sildenafil 40 mg
Drug: Sildenafil 40 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days
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)
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
7 days
Frequency and severity of adverse drug events during treatment, as compared to placebo
Time Frame: 7 days
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
Week 1, 2 and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jean-Luc CRACOWSKI, MD, INSERM CIC03 - Unité de Pharmacologie Clinique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (ESTIMATE)

January 30, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2016

Last Update Submitted That Met QC Criteria

January 15, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC/12/26
  • 2013-000014-38 (EUDRACT_NUMBER)
  • 12G01 (OTHER: Promotor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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