Topical Amlodipine in Raynaud's Phenomeno
- Conditions
- The medical conditions under investigation in this trial are as follows:1] Primary Raynaud's Phenomenon2] Systemic Sclerosis (SSc) - otherwise known an Seconday Raynaud's Phenomenon.Raynaud's phenomenon is a disorder that affects the blood vessels in the fingers, toes, ears, and nose. This disorder is characterized by episodic attacks, called vasospastic attacks, that cause the blood vessels in the digits (fingers and toes) to constrict (narrow).
- Registration Number
- EUCTR2009-018194-31-GB
- Lead Sponsor
- Pharmarama International Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 45
•Subject must give written informed consent for participation in the trial
•Subject age (Male or Female), 18 years or older
•Subjects with PRP(Primary Raynaud's Phenomenon) will have had Raynaud’s phenomenon for at least two years, with neither clinical nor serological evidence of connective tissue disease, and be attending the regional specialist Raynaud’s & Scleroderma clinic at University Hospital Aintree
•The patients with SSc(Systemic Scerolosis) will have established disease, and be attending the regional specialist Raynaud’s & Scleroderma clinic at University Hospital Aintree
•Control subjects will have no Raynaud’s phenomenon nor connective tissue disease and will be recruited from subjects without inflammatory arthritis / connective tissue disease who are attending the rheumatology and orthopaedic clinics
•Subjects must be willing to stop all other concomitant vasodilator preparations 2 weeks prior to the study
•Subjects must avoid caffeine ingestion and smoking on the day of the test
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Subjects unwilling to participate
•Subjects with hypertension, known hypercholesterolaemia, diabetes mellitus or any history of atherosclerosis (ischaemic heart disease, previous myocardial infarction, previous cerebrovascular accident / transient ischaemic attack or peripheral vascular disease).
•Subjects with significant aortic stenosis and cardiogenic shock
•Subjects with acute porphyria
•Subjects with known hypersensitivity to amlodipine.
•Subjects requiring continued treatment with vasodilators.
•Subjects who suffer from hypotension (including postural hypotension)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the efficacy of Amlodipine Maleate gel in improving digital blood flow;Secondary Objective: 1] To ascertain the practicality of Amlodipine Maleate Gel application<br>2] To establish short term side effect profile;Primary end point(s): 1] Improve patients symptoms by increasing blood flow to the finger extremeties<br>
- Secondary Outcome Measures
Name Time Method