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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42564   clinical trials with a EudraCT protocol, of which   7007   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

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    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2012-003077-26
    Sponsor's Protocol Code Number:IMIVER
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-01
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2012-003077-26
    A.3Full title of the trial
    Topical lidocaine for the treatment of focal peripheral neuropathic pain: response in relation to pain phenotype
    Topikalt lidokain til fokal perifer neuropatisk smerte: respons i forhold til fænotypen for smerterne
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of focal nerve pain with lidocaine patch
    Behandling af lokale nervesmerter med lidokain plaster
    A.3.2Name or abbreviated title of the trial where available
    Treatment of focal neuropathic pain with lidocaine patch
    Behandling af lokal neuropatisk smerte med lidokain plaster
    A.4.1Sponsor's protocol code numberIMIVER
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDepartment of Neurology, Odense University Hospital
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGrünenthal Denmark APS
    B.4.1Name of organisation providing supportIMI EUROPAIN
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Neurology, Odense University Hospital
    B.5.2Functional name of contact pointSøren hein Sindrup
    B.5.3 Address:
    B.5.3.1Street AddressSøndre Boulevard 29
    B.5.3.2Town/ cityOdense
    B.5.3.3Post code5000
    B.5.4Telephone number+4565412471
    B.5.5Fax number+4565413389
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D. name Versatis 5% Medicinsk plaster
    D. of the Marketing Authorisation holderGrunenthal GmbH
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Cutaneous patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIDOCAINE
    D.3.9.1CAS number 137-58-6
    D.3.9.4EV Substance CodeSUB08507MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5%
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCutaneous patch
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical 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
    E.1.1.1Medical 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
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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).
    E.2.2Secondary 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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(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
    E.5.2Secondary 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.
    E.5.2.1Timepoint(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)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 23
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state46
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If pain relief, the patient can continue with topikal lidocaine after the trial.
    Otherwise the patient is offered pain treatment according to the standard of the department
    Ved smertelindring kan patienten forsætte med topikal lidokain efter forsøget.
    Ellers tilbydes behandling i henhold til afdelingens standard
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Good Clinical Practic Unit
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-14
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