The Influence of Ivabradine on the Symptoms of Neuropathic Pain (IISNeP)
- Conditions
- europathic PainMedDRA version: 14.0Level: PTClassification code 10029223Term: NeuralgiaSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-003933-32-GB
- Lead Sponsor
- Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
- Volunteers who have given written, informed consent to participate. - Volunteers who can communicate fluently in English.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
- Volunteers not giving consent to participate. - Volunteers who cannot communicate fluently in English. - Volunteers with 1 arm - Volunteers who are allergic to ivabradine, capsaicin or Tegaderm. - Volunteers for whom ivabradine is contraindicated: namely sick sinus syndrome and concomitant use of CYP3A4 inhibitors such as ketoconazole, macrolide antibiotics, nefazodone and the anti-retrovirals nelfinavir and ritonavir. - Volunteers with any rash or broken skin on the forearm where capsaicin will be applied. - Volunteers with lactose intolerance. - Volunteers with a resting pulse rate of 59 beats per minute or less at screening or on the day of the study. - Volunteers who are pregnant - Volunteers who have any underlying medical condition such as migraine or epilepsy which may affect the study findings - Volunteers who smoke, take recreational drugs or consume more than the recommended allowance of alcohol units per week
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method