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    Summary
    EudraCT Number:2013-000521-31
    Sponsor's Protocol Code Number:PI12_01813
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-000521-31
    A.3Full title of the trial
    Efficacy and safety of gabapentin versus placebo to prevent the incidence of PostHerpetic Neuralgia
    Ensayo clínico, aleatorizado, doble-ciego para evaluar la eficacia y seguridad de la gabapentina frente a placebo en la prevención de la neuralgia postherpética
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess if gabapentine could prevent the postherpetic neuralgia in patient with Herpes zoster if treated the first 72 hour of the onset.
    Estudio con asignacion al azar de los pacientes para determinar si la gabapentina administrada en las primeras 72h de los primeros sintomas del Herpes Zoster previene la aparición de la neuralgia postherpetica.
    A.4.1Sponsor's protocol code numberPI12_01813
    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 SponsorGerencia de Atención Primaria de Mallorca
    B.1.3.4CountrySpain
    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 supportInstituto de Salud Carlos iii (isciii)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationResearch Unit/ Gerencia de Atención Primaria Mallorca
    B.5.2Functional name of contact pointDr. Joan Llobera Canavés
    B.5.3 Address:
    B.5.3.1Street AddressC/Reina Esclaramunda n 9
    B.5.3.2Town/ cityPalma de Mallorca
    B.5.3.3Post code07003
    B.5.3.4CountrySpain
    B.5.4Telephone number0034971175883
    B.5.5Fax number0034971175888
    B.5.6E-mailjllobera@ibsalut.caib.es
    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.2.1.1.1Trade name GABAPENTINA KERN PHARMA
    D.2.1.1.2Name of the Marketing Authorisation holderKERN PHARMA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGABAPENTINA
    D.3.9.1CAS number 060142-096-3
    D.3.9.2Current sponsor code781443
    D.3.9.3Other descriptive nameGABAPENTIN
    D.3.9.4EV Substance CodeSUB07857MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postherpetic Neuralgia
    Neuralgia Postherpetica
    E.1.1.1Medical condition in easily understood language
    Postherpetic Neuralgia
    Neuralgia Postherpetica
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of optimal doses of gabapentin for 5 weeks in the acute phase of herpes zoster in patients>= 50 years with moderate to severe pain added to the usual treatment to reduce the percentage of patients without post-herpetic neuralgia at 12 weeks.
    Evaluar la eficacia del tratamiento con gabapentina a dosis óptima durante 5 semanas en la fase aguda del Herpes Zóster en pacientes >= 50 años y con dolor moderado o intenso, añadida al tratamiento habitual en la reducción del porcentaje de pacientes sin neuralgia postherpetica a las 12 semanas.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of optimal doses of gabapentin for 5 weeks in the acute phase of herpes zoster added to the usual treatment.....

    to reduce the percentage of patients without post-herpetic neuralgia at 6 weeks.

    to reduce the percentage of patients with a reduction >= to 50% in the analogic visual analog scale of pain at 12 weeks.

    To evaluate the security of optimal doses of gabapentin for 5 weeks in the acute phase of herpes zoster added to the usual treatment in terms of porcentage of patient with adverse events and adverse effect to the treatment.

    To evaluate que quality of life by the SF-12 scale of patient treated with gabapentine compare to placebo patients.
    Evaluar la eficacia del tratamiento con gabapentina a dosis óptima durante 5 semanas, en la fase aguda del Herpes Zóster en pacientes >= 50 años, con dolor moderado-intenso añadida al tratamiento habitual en términos de:
    - Porcentaje de pacientes que mejoran la sintomatología de NPH a las 6 y 12 semanas del inicio del cuadro agudo (definida como una reducción >= 50% de la puntuación en la escala EVA de dolor respecto al basal)
    - Mejora en la puntuación de la escala SF-36.
    - Evaluar la seguridad del tratamiento con gabapentina a dosis óptima durante 5 semanas añadida al tratamiento habitual del Herpes Zóster en términos de Acontecimientos Adversos (AA).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient aged >= 50 , diagnosed by uncomplicated herpes zoster with a < de 72h onset.

    Visual analog scale of pain ? 4 (rated 0 to 10).
    Pacientes >= 50 años, con diagnóstico de herpes zoster no complicado de < de 72h de evolución.

    Pacientes con dolor moderado a intenso (puntuación del dolor en la escala EVA >=4)
    E.4Principal exclusion criteria
    Current or anticipated treatment with gabapentine or triciclys antidepresants

    Patients diagnosed of hepatic insufficiency

    Patients with a a history of intolerance of hipersensitivity to gabapentin or excipients.

    Patients with impaired renal function (Clcr <79ml/min)

    Patients with evidence of cutaneous, ocular or visceral disemination of herpes zoster infection (cutaneous disemination is defined as > 20 discrete lesion outside adjacent dermatomes) evidencia de diseminación cutánea o visceral del HZ (más de 20 lesiones fuera del
    dermatoma adyacente)

    Patients who have received inmunosupresive therapy in the last 3 months or inmunomodulatory medication (including interferon) within the previous 4 weeks
    Patient diagnosed of inmunodeficiency
    Pacientes en tratamiento habitual con gabapentina o antidepresivos triciclicos.

    Pacientes diagnósticados de insuficiencia hepática grave.

    Pacientes que presenten hipersensibilidad a la sustancia activa o a alguno de los excipientes.

    Pacientes con insuficiencia renal alterada (Clcr <79ml/min).

    Pacientes con evidencia de diseminación cutánea o visceral del HZ (más de 20 lesiones fuera del dermatoma adyacente) o afectación oftálmica.

    Pacientes en tratamiento inmunosupresor en los últimos 3 meses, diagnóstico de
    inmunodeficiencia de cualquier tipo, tratamiento inmunomodulador (interferon) en las últimas 4 semanas.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients without post-herpetic neuralgia defined as a score of 0 in the visual analog scale of pain.
    Porcentaje de pacientes sin NPH al final de seguimiento a las 12 semanas (definida como puntuación 0 en la Escala Visual Analógica (EVA) de dolor.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 12 weeks from inclusion
    A las 12 semanas
    E.5.2Secondary end point(s)
    percentage of patients without post-herpetic neuralgia at 6 weeks.
    percentage of patients with a reduction >= to 50% in the analogic visual analog scale of pain at 12 weeks.
    porcentage of patient with adverse events and adverse effect to the treatment.
    Patient SF-12 rating score at 6 and 12 weeks
    Porcentaje de pacientes sin NPH a las 6 semanas de inicio del cuadro agudo definida como puntuación 0 en la escala EVA de dolor.
    Porcentaje de pacientes considerados respondedores que mejoran la sintomatología de NPH a las 6 y las 12
    semanas del inicio del cuadro agudo: Definimos respondedores a aquellos pacientes que consiguen una reducción >= al 50% de la puntuación en la escala EVA de dolor respecto al basal.

    Puntuación en la escal SF-12 a las 6 y 12 semanas
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 or 12 weeks as indicate above
    6 o 12 semanas según ha sido indicado en el apartado anterior.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.6Cross over No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state134
    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)
    none
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-26
    P. End of Trial
    P.End of Trial StatusCompleted
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