Chronic peripheral neuropathic pain caused by postherpetic neuralgia and traumatic/surgical nerve injury MedDRA version: 14.1 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Versatis 5% Medicinsk plaster
Pharmaceutical Form: Cutaneous patch
INN or Proposed INN: LIDOCAINE
CAS Number: 137-58-6
Concentration unit: % (V/V) percent volume/volume
Concentration type:
Sponsors
Department of Neurology, Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 46 patients (23 with irritable and 23 with non-irritable nociceptors) aged 18 or more with postherpetic neuralgia or neuropathic pain after a peripheral nerve injury with a pain intensity of at least 4 on a 0-10 point numeric rating scale 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 23 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: Exclusion criteria include pregnancy or lactation, allergy to lidocaine or to other amide type local anaesthetics, alcohol abuse, psychiatric disorders, inflamed or injured skin in the area where the patches are to be applied, and treatment with class I antiarrhythmic agents, as well as severe cardiac, renal or hepatic impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to determine if the response to topical lidocaine in focal peripheral neuropathic pain depends on pain phenotype (irritable vs. non-irritable nociceptor).;Secondary Objective: -to test the effect of topical lidokaine on different pain phenomena in peripheral neuropathic pain. -to test if the effect of topical lidokaine depends on presence of pain paraxysms. - to test if the effect of topical lidocaine dependes on pain characteristics as determined by Neuropathic Pain Symptom Inventory. -to test if the effect of topical lidocaine dependes on the sensory profile (quantitative sensory testing) -to test if the effect of topical lidocaine on peripheral neuropathic pain depends on normal or abnormal thermal detection ;Primary end point(s): Pain rating on the 0-10 numeric scale will serve as the primary efficacy variable. A mean value of the ratings during the baseline period and during the last week in each treatment period will be used in the statistical analysis. The delta value lidocaine-placebo will serve as the primary efficacy parameter to be analyzed;Timepoint(s) of evaluation of this end point: A mean value of the ratings during the baseline period and during the last week in each treatment period (week 4) will be used in the statistical analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary effect variable will be 1) Pain relief ( complete, good, moderate, slight, none or worse). 2) Effect on brush evoked allodynis, cold allodynia and pinprick hyperalgesia. 4)Escape medication (paracetamol and tramadol) ;Timepoint(s) of evaluation of this end point: Week 4 of each treatment period (end of treatment period) | — |
Countries
Denmark
Contacts
Public ContactSøren hein Sindrup
Department of Neurology, Odense University Hospital
Outcome results
None listed