Patients with proven diagnosis of painful peripheral neuropathic pain syndromes as diagnosed as: 1. Peripheral nerve lesion or 2. Postherpetic neuralgia. MedDRA version: 14.0 Level: PT Classification code 10036376 Term: Post herpetic neuralgia System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.0 Level: PT Classification code 10034586 Term: Peripheral nerve injury System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: Versatis
Pharmaceutical Form: Cutaneous patch
INN or Proposed INN: LIDOCAINE
CAS Number: 137-58-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 700-
P
Sponsors
BG University Hospital Bergmannsheil GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Included will be patients 18 years and older either genera with: -Proven Diagnosis of painful peripheral neuropathy for at least 3 months as diagnosed as: 1. Peripheral nerve lesion (i.e. pain within or adjacent to the area of nerve trauma or corresponding innervation territory or dermatome) or 2. Postherpetic neuralgia (Subjects with pain following herpes zoster with > 3 months after healing of herpes zoster skin rash). - At least moderate pain intensity under the current treatment. - Unchanged and stable pain medication within the last 4 weeks. - The patients have to display some remaining sensory function at the baseline QST. - Intact skin in the area of lidocaine medicated plaster application. - Females with childbearing potential must be using adequate contraception. - Women of childbearing potential must have a negative urine ß-human chorionic gonadotropin (ß-HCG) pregnancy 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Excluded will be patients with: - History of current alcohol or drug abuse. - Any scheduled surgery of painful procedure during the course of the trial. - Presence of a disease that affects the subject’s compliance. - Use of any topical anaesthetics in the area of pain within the last 6 months. - Use of capsaicin (low or high-dose) in the area of pain within the last 6 months. - Use of TENS within the area of pain in the last 4 weeks. - Subjects who had nerve ablation by block or neurosurgical intervention for pain treatment at the affected area. - Evidence or another cause of pain within the area of pain or another severe pain condition that may interfere with the trial aims or procedures. - Severe loss of sensory function - Contraindications or hypersensitivity to local anaesthetics of amide type or to any of the exipients. - Intake of class I antiarrhythmic drugs (e.g. tocainide, mexilitine). - Use of systemically applied local anaesthetics within the last 4 weeks - Active herpes zoster lesion, dermatitis or skin lesions of any origin within the area of pain. - Clinically relevant cardiac insufficiency (NYHA Class III to IV) - Clinical relevant severe impairment of the kidney or liver function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of this trial is the assessment of the pain relief in patients suffering from peripheral neuropathic pain after treatment by topical application of lidocaine (5%). ;Secondary Objective: - Other sensory profile alterations in patients after treatment.;Primary end point(s): - The amount of pain relief (NRS-3) - Number of treatment responders (as defined as subjects with a decrease of average pain (NRS-3) by > 30% at Visit 3 and Visit 5). - Decrease of A-delta- and C-fiber function after treatment using topical application of lidocaine (5%) or placebo.;Timepoint(s) of evaluation of this end point: NRS-3 at Visit 3 (day 21) and Visit 5 (day 42) compared to baseline NRS-3 at Visit 2 (day 7) and 4 (day 24) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Changes of other QST parameters (tactile detection thresholds, thermal or mechanical hyperalgesia, dynamic mechanical allodynia). - To assess the symptom intensity and their possible changes after application of lidocaine (5%) the PainDETECT and NPSI (German version) questionnaire will be used at baseline and at each obligatory follow-up, the Patient Global Impression of Change scale (PGIC) will be used as a non-specific tool as well. - During the treatment a patient’s diary including the current, average and maximum pain intensity will be documented as well the intensity of some other complaints (e.g. nausea, drowsiness, sleep disorder etc.). ;Timepoint(s) of evaluation of this end point: see E.5.2 | — |
Countries
Germany
Outcome results
None listed