Neuropathic pain due to Peripheral nerve damage MedDRA version: 12.1 Level: HLT Classification code 10011302 Term: Peripheral nerve injuries MedDRA version: 12.1 Level: LLT Classification code 10034586 Term: Peripheral nerve injury
Conditions
Interventions
Trade Name: Versatis 5% medicated plaster
Product Name: Versatis 5% medicated plaster
Product Code: PL21727/0016
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: lidocaine
CAS Number: 137-5
Sponsors
Danish Pain Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with focal neuropathic pain for at least 3 months following a peripheral nerve injury due to trauma or surgery are eligible. The neuropathic pain should be within a skin area with positive or negative sensory signs corresponding to the territory of the injured peripheral nerve/nerves 2. Patients aged 18 years or above with a pain intensity of at least 4 on a 0-10 point NRS scale at the first visit (screening) 3. Intact skin i the area where the plaster is to be applied. 4. Written informed consent has been obtained. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Other diseases: Diabetes, symptomatic cardiovascular, liver or kidney diseases, neurological diseases other than peripheral nerve injury. 2. Other pains that may make it difficult to discriminate these pains from the pain originating from the nerve injury. 3. Allergy to lidocaine or some of the substances in the medicine. 4. Skin diseases in the area where the patches are to be applied. 5. Pregnant or lactating women. Fertile women must be in sufficient contraception and have a negative pregnancy test. 6. Persons who cannot cope with the study or are unable to conduct the study because of lack of understanding of danish, mental illness, abuse of alcohol or drugs. 7. Patients who are in treatment with class I antiarrhythmic agents. 8. Patients who were in treatment with Na2+ -channel blockers in the recent month or in treatment with capsaicin in the recent 3 months. 9. Patients in treatment with TENS or acupuncture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary purpose is to study the predictive value of preserved nociceptors and large afferent fibers and dynamic mechanical allodynia on the effect of lidocaine patch (Versatis 5% medicated plaster). The primary outcome measure is the predictive role for these measures for obtaining a response to lidocaine. A responder is defined as a person with at least a 2-point reduction in median pain intensity (measured from a baseline week to the last week of treatment). ;Secondary Objective: Pain assesments reported by the patients with the use of questionnaires.;Primary end point(s): The primary endpoint is the predictive role for these measures in obtaining a response to lidocaine. A responder is defined as a person with at least a 2-point reduction in median pain intensity (measured from the baseline week to the last week of treatment, measured on the NRS scale 0-10). AMENDMENT: Because of technical difficulties and the inappropriateness of using SEP in our patient population, we are not performing somatosenory evoked potential examinination (SEPs). The study objective is to evaluate if the degree of preserved nociceptors (Ad and C fibers), Aß fibers and and the degree of dynamic mechanical allodyni can be used as a predictor for the effect of Versatis lidocaine patch. We are therefore using vibration thresholds as the only tool to examine the conserved large nerve fibers (Aß fibers). | — |
Countries
Denmark
Outcome results
None listed