NCT02050360

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 18, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

January 28, 2014

Last Update Submit

January 15, 2016

Conditions

Raynaud's Phenomenon

Keywords

Raynaud's phenomenonSildenafilSystemic SclerosisLocal coolingMicrocirculation

Outcome Measures

Primary Outcomes (1)

  • Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo.

    RCS is self-reported every day and averaged over 7-day periods

    7 days

Secondary Outcomes (5)

  • Frequency of RP: number of RP attacks during treatment, as compared to placebo.

    7 days

  • Patients' preference: comparison between the number of patients favoring a treatment to another.

    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.

    7 days

  • Frequency and severity of adverse drug events during treatment, as compared to placebo

    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)

    Week 1, 2 and 3

Study Arms (3)

Sildenafil 80 mg

EXPERIMENTAL

Sildenafil 80 mg

Drug: Sildenafil 80 mg

Sildenafil 40 mg

EXPERIMENTAL

Sildenafil 40 mg

Drug: Sildenafil 40 mg

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Sildenafil 40 mgDRUG
Sildenafil 40 mg
Sildenafil 80 mgDRUG
Sildenafil 80 mg
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active Raynaud's Phenomenon characterized by a clinical history of primary or secondary Raynaud's Phenomenon
  • Patients who have dated and signed the informed consent form
  • Contraception for women

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble

Grenoble, France

Location

Related Publications (2)

  • Maltez N, Maxwell LJ, Rirash F, Tanjong Ghogomu E, Harding SE, Tingey PC, Wells GA, Tugwell P, Pope J. Phosphodiesterase 5 inhibitors (PDE5i) for the treatment of Raynaud's phenomenon. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD014089. doi: 10.1002/14651858.CD014089.

    PMID: 37929840DERIVED

  • Roustit M, Giai J, Gaget O, Khouri C, Mouhib M, Lotito A, Blaise S, Seinturier C, Subtil F, Paris A, Cracowski C, Imbert B, Carpentier P, Vohra S, Cracowski JL. On-Demand Sildenafil as a Treatment for Raynaud Phenomenon: A Series of n-of-1 Trials. Ann Intern Med. 2018 Nov 20;169(10):694-703. doi: 10.7326/M18-0517. Epub 2018 Oct 30.

    PMID: 30383134DERIVED

MeSH Terms

Conditions

Raynaud DiseaseScleroderma, Systemic

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Livedoid VasculopathyThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesConnective Tissue Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jean-Luc CRACOWSKI, MD

    INSERM CIC03 - Unité de Pharmacologie Clinique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

November 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 18, 2016

Record last verified: 2016-01

Locations

FR(1)