Topical Amlodipine in Raynaud's Phenomenon

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-018194-31-GB
• Date of registration: 18/03/2010
• Prospective Registration: Yes
• Primary sponsor: Pharmarama International Limited
• Public title: Topical Amlodipine in Raynaud's Phenomenon
• Scientific title: Topical Amlodipine in Raynaud's Phenomenon
• Date of first enrolment: 03/11/2010
• Target sample size: 45
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-018194-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
• 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

Exclusion criteria:
• 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)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

The medical conditions under investigation in this trial are as follows: 1] Primary Raynaud's Phenomenon 2] 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).

Intervention(s)

Product Name: Amlodipine Gel
Product Code: AM-01
Pharmaceutical Form: Gel
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Topical use (Noncurrent)

Primary Outcome(s)

Secondary Objective: 1] To ascertain the practicality of Amlodipine Maleate Gel application
2] To establish short term side effect profile

Main Objective: To determine the efficacy of Amlodipine Maleate gel in improving digital blood flow

Primary end point(s): 1] Improve patients symptoms by increasing blood flow to the finger extremeties

Secondary ID(s)

PIL001