Raynaud's Phenomenon
Conditions
Keywords
Raynaud's phenomenon, Sildenafil, Systemic Sclerosis, Local cooling, Microcirculation
Brief summary
The purpose of this study is to determine whether on-demand sildenafil is effective in the treatment of Raynaud's phenomenon.
Interventions
DRUGSildenafil 40 mg
DRUGSildenafil 80 mg
DRUGPlacebo
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo. | 7 days | RCS is self-reported every day and averaged over 7-day periods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of RP: number of RP attacks during treatment, as compared to placebo. | 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 |
| 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 | 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 | 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 | — |
Countries
France
Outcome results
None listed