E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic peripheral neuropathic pain caused by postherpetic neuralgia and traumatic/surgical nerve injury |
Kronisk perifer neuropatisk smerte forårsaget af postherpetisk neuralgi eller perifer nerveskade på grund af traume/ postoperativ |
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E.1.1.1 | Medical condition in easily understood language |
Nerve pain caused by shingles or nerve injury as a result of trauma/surgery |
Nervesmerter forårsaget af helvedesild eller som følge af nerveskade på grund af traume eller kirurgi |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054095 |
E.1.2 | Term | Neuropathic pain |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
Formålet med studiet er at undersøge om effekten af topikalt lidokain ved fokal perifer neuropatisk smerte afhænger af smerte fænotypen (irritable ve. non-irritable nociceptorer). |
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E.2.2 | Secondary objectives of the trial |
-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 |
-at teste effekten af lokalt appliceret lidokain på forskellige specifikke smertefænomener ved perifer neuropatisk smerte.
-at teste om effekten af lokalt appliceret lidokain på kroniske perifere neuropatiske smerter afhænger af om patienterne har smerteparoxysmer eller ej.
-at teste om effekten af topikalt lidokain på kroniske perifere neuropatiske smerter afhænger af smertekarakteristika (5 dimensioner af NPSI).
-at teste om effekten af lokalt appliceret lidokain på kroniske perifere neuropatiske smerter afhænger af patienternes sensoriske profil.
-at teste om effekten af topikalt lidokain på kroniske perifere neuropatiske smerter afhænger af om patienten har normal eller abnorm kuldedetektion.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
46 patienter (23 med irritable nociceptor og 23 med non-irrtable nociceptor), alder 18 eller der over, med postherpetisk neuralgi eller neuropatisk smerte efter perifer nerveskade med en smerteintensitet på mindst 4 på en mumerisk skala 0-10, vil inkluderes
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E.4 | Principal 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. |
allergiske reaktioner overfor over for lidokain plaster eller lokalanalgetika af amidtypen, alkoholmisbrug.
kendte uønskede reaktioner på lidokain behandling.
Graviditet eller ammeperiode.
Betydende nyre eller leverpåvirkning
Depression eller andre betydende psykiatriske sygdomme.
Beskadiget eller inflammeret hud hvor plasteret skal appliceres.
Behandling med klasse Ia antiarytmika.
Svær hjerte, nyre eller leversygdom |
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E.5 End points |
E.5.1 | 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 |
Den primære effektvariabel vil være ændring i smerte intensitet målt på numerisk rating skala (0 – 10 point). Ændringen fra middel værdi for baseline uge til middelværdi for den sidste uge i hver behandlingsperiode beregnes. Delta værdien for lidokain vs. placebo vil blive brugt som den primære effekt parameter ved analysen. |
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E.5.1.1 | 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. |
Middel værdien for baseline uge og middel værdien for den sidste uge i hver behandlingsperiode ( uge 4 ) vil blive brugt i den statistiske analyse |
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E.5.2 | 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) |
Sekundære effekt mål vil være 1) Smertelindring ( fuldstændig, god, moderat, let, ingen eller værre). 2) Rating af allodyni evokeret med børste og kulde, samt pinprick. 4) Escape medicin. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 4 of each treatment period (end of treatment period) |
Uge 4 af hver behandlingsperiode (afslutning af behandlingsperiode) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Trail will end when 46 patients have completed and at least 23 of these of these are patients with irritable nociceptor phenotype |
Forsøget vil afsluttes når 46 patienter har gennemført og mindst 23 af disse patienter, er patienter med irritable nociceptor fænotypen |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |