"As Required" Oral Sildenafil in Raynaud's Phenomenon
Phase 2
Completed
- Conditions
- Raynaud's Phenomenon
- Interventions
- Registration Number
- NCT02050360
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
The purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of Raynaud's phenomenon.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sildenafil 80 mg Sildenafil 80 mg Sildenafil 80 mg Sildenafil 40 mg Sildenafil 40 mg Sildenafil 40 mg Placebo Placebo placebo
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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) 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 Frequency and severity of adverse drug events during treatment, as compared to placebo 7 days 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
Trial Locations
- Locations (1)
Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble
🇫🇷Grenoble, France