Neuropathic Pain MedDRA version: 14.0 Level: PT Classification code 10029223 Term: Neuralgia System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Procorolan
Product Name: Ivabradine
Pharmaceutical Form: Tablet
INN or Proposed INN: Ivabradine
CAS Number: 148849-67-6
Concentration unit: mg milligram(s)
Concentration type: equal
Pharma
Sponsors
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We will examine whether ivabradine reduces the intensity of certain symptoms that are associated with nerve (neuropathic) pain. We can temporarily induce neuropathic pain in the skin of volunteers by applying a cream containing capsaicin: the chemical in chilli peppers that make it hot. This creates a warm area on the skin, and another area around it where changes in the nerves make it more sensitive. The changes in this area (known as the area of secondary hyperalgesia) can also be found in nerve pain. The changes can be measured with a technique called quantitative sensory testing. We will be particularly interested in measuring volunteers' response to heat, called the heat threshold, and whether this is altered by ivabradine. Ivabradine is a drug that is used to treat people with angina, but new evidence from experiments in animals suggests that it can profoundly reduce neuropathic pain.;Secondary Objective: The equipment that measures peoples' heat thresholds can also measure thresholds at which they can detect cool and warm sensations, and painful coldness. We will measure these parameters as well. We will need to map the area of sensitivity, by taking a digital photograph, and record the area over which the volunteers can feel changes in normal sensation, for example gentle brushing with cotton wool and gentle pressure. We will also ask the participants to score the pain elicited by the capsaicin by placing a cross on a 10cm scale. Generally, this is between two and three out of ten, so it might be that this study does not have sufficient power to detect a difference. What is important in this early study is to see if the ivabradine reduces the effects on the thresholds. If so, it would suggest that a larger clinical trial in patients would be worthwhile. …).;Primary end point(s): The primary endpoint is volunteers' thresholds to heat, as as measured by quantitative sensory testing (contact heat evoked potentials, CHEPs). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint is volunteers pain scores as measured by the VAS questionnaire.;Timepoint(s) of evaluation of this end point: All data will be evaluated at following the last participant last visit. | — |
Countries
United Kingdom
Contacts
Public ContactMrs Carrie Bayliss
Cambridge Clinical Trials Unit
Outcome results
None listed