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Completed

NCT Number: NCT02050360

"As Required" Oral Sildenafil in Raynaud's Phenomenon

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

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Key information

Conditions

Raynaud's Phenomenon Cardiovascular Diseases Connective Tissue Diseases Embolism and Thrombosis Livedoid Vasculopathy Peripheral Vascular Diseases Raynaud Disease Scleroderma, Systemic Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble

Grenoble, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil 40 mg

Drug

Sildenafil 80 mg

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: PROFIL

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 30, 2014
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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