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    Summary
    EudraCT Number:2012-000399-41
    Sponsor's Protocol Code Number:ESTEVE-SIGM-203
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-29
    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 number2012-000399-41
    A.3Full title of the trial
    An exploratory, randomized, double blind, placebo controlled, parallel groups Phase II clinical trial to evaluate the efficacy and safety of E-52862 (400 mg) by oral route, in patients with postherpetic neuralgia (PHN).
    Ensayo clínico exploratorio en fase II, aleatorizado, doble ciego, controlado con placebo y con grupos paralelos para evaluar la eficacia y seguridad de E-52862 (400 mg) por vía oral en pacientes con neuralgia postherpética (NPH).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the efficacy and safety of E-52862 ( 400 mg) by oral route, in patients with post herpetic neuralgia (PHN).
    Estudio para evaluar la eficacia y seguridad de E-52862 (400 mg) por via oral en pacientes con neuralgia postherpética (NPH).
    A.4.1Sponsor's protocol code numberESTEVE-SIGM-203
    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 SponsorLaboratorios del Dr. Esteve. S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLaboratorios del Dr. Esteve. S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios del Dr. Esteve. S.A.
    B.5.2Functional name of contact pointStudy Medical Monitor
    B.5.3 Address:
    B.5.3.1Street AddressAvda Mare de Déu de Montserrat, 221
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08041
    B.5.3.4CountrySpain
    B.5.4Telephone number+34934466124NA
    B.5.5Fax number+34934466110NA
    B.5.6E-mailrvives@esteve.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 No
    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.3.1Product nameNA
    D.3.2Product code E-52862
    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.3.9.1CAS number 878141-96-9
    D.3.9.2Current sponsor codeE-52862
    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 Postherpética
    E.1.1.1Medical condition in easily understood language
    Postherpetic Neuralgia
    Neuralgia Postherpética
    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 PT
    E.1.2Classification code 10036376
    E.1.2Term Post herpetic neuralgia
    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 primary objective of this study is to assess the analgesic efficacy of E-52862 in subjects with moderate to severe postherpetic neuralgia
    El objetivo principal de este estudio es evaluar la eficacia analgésica de E-52862 en pacientes con neuralgia postherpética de moderada a intensa
    E.2.2Secondary objectives of the trial
    To describe the safety and tolerability profile of E-52862 when administered during 28 days to patients with moderate to severe postherpetic neuralgia.
    To assess E-52862 plasma exposure associated with a pharmacodynamic response after administration of repeated oral doses for 28 days in patients with moderate to severe postherpetic neuralgia.
    Describir el perfil de seguridad y tolerabilidad de E-52862 cuando se administra durante 28 días a pacientes con neuralgia postherpética de moderada a intensa.
    Evaluar la exposición plasmática a E-52862 asociada con una respuesta farmacodinámica tras la administración de dosis orales repetidas durante 28 días en pacientes con neuralgia postherpética de moderada a intensa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female ? 18
    2.Patients with Herpes Zoster (HZ) with pain persistent at least one month but less than 3 months after the rash onset.
    3.Patients at screening visit must have a moderate to severe pain intensity measured by a score ? 4 on the NPRS
    4.Patients who provide a signed informed consent prior to study entry
    5.Subjects must agree to use acceptable methods of contraception
    6.Be willing and able to understand and comply with protocol requirements for the durations of study participation
    1.Hombres y mujeres mayores de 18 años.
    2.Pacientes con diagnóstico de neuralgia postherpética presente durante más de 3 meses desde la resolución de la erupción cutánea, pero no más de 5 años.
    3.Pacientes tratados con dosis estables de gabapentina o pregabalina durante al menos un mes antes de la visita de selección y que pueden continuar tomando las mismas dosis durante todo el estudio a criterio del investigador.
    4.En el momento de la visita de selección, los pacientes deben presentar un dolor de moderado a intenso, determinado mediante una puntuación ? 4 en la escala NPRS.
    5.Los pacientes deben presentar un dolor de moderado a intenso (es decir, una puntuación media ? 4 en la escala NPRS) durante los 7 días previos a la visita 2 (día -1). Los pacientes deben tener al menos cinco evaluaciones de la puntuación media diaria de la intensidad del dolor de 24 horas, registradas durante el periodo de preinclusión de siete días de duración.
    6.Pacientes que otorguen su consentimiento informado firmado antes de entrar en el estudio.
    7.Las pacientes deben comprometerse a utilizar métodos anticonceptivos aceptables (véase la sección 5.1).
    8.Voluntad para entender y cumplir con los requisitos del protocolo durante toda la participación en el estudio.
    E.4Principal exclusion criteria
    1.Pregnant or nursing women
    2.Patients having severe pain related to other causes
    3.Exposure in the previous 30 days to drugs known to cause neuropathy (as described in section 6.2.2 Prohibited medication)
    4.Major psychiatric disorder
    5.Serious or unstable cardiovascular disease that could compromise participation or cause hospitalization during the study
    6.Second or third degree atrioventricular blockade not corrected with a pacemaker or any clinically significant abnormality in the 12 lead electrocardiogram as determined by the investigator
    7.Subjects taking the following drug classes and individual drugs which cannot discontinue their use, are excluded:
    -benzodiazepines (except short half-life sleep agents)
    -skeletal muscle relaxants
    -orally administered steroids
    -centrally acting analgesics (dextromethorphan, tramadol)
    -opiates
    -topical lidocaine or capsaicin
    -NSAID
    -Anticonvulsants other than gabapentin and pregabalin
    -tricyclic, selective serotonin reuptake inhibitor (SSRI) or serotonin and noradrenalin reuptake inhibitor (SNRI) antidepressants
    -NMDA antagonists
    -Thalidomide
    -Nitrous oxide
    -Ca++/Mg++ infusions
    In case of discontinuation, these drugs require a minimum washout period of at least 5 times the half life and should be tapered appropriately using product label instructions as a guide before the patient enters the run in period of the study
    8.Subjects taking gabapentin or pregabalin for which the dosage has been changed within the month previous to the screening visit.
    9.History of any active serious medical conditions that, in the investigator's opinion, can compromise the subject's safety or interfere with the study assessments.
    10.History of drug abuse or dependence (drug categories defined by DSM IV) within the past year, excluding nicotine and caffeine.
    11.Subjects who, in the previous 30 days, received treatment with a drug that had not received regulatory approval for any indication at the time of study entry.
    12.History of severe gastroparesis or gastric bypass surgery.
    13.Previous neurolytic or neurosurgical treatment for the studied neuropathic pain.
    14.Injected anesthetics or steroid use within 30 days of Visit 1.
    15.Malignancy within past 2 years.
    16.Has a known history of a positive (HIV) antibody test or known HIV infection
    17.Has a known history of positive Hepatitis B or C virus serology indicative of active acute or chronic infection
    18.Unable to comply with the study procedures
    19.Patients with the following laboratory values abnormalities:
    -ALT, AST and GGT > 2 x ULN
    -Neutrophils < 1500/mm3
    -Lymphocytes < 1000/ mm3
    -Haemoglobin < 10 g/dL
    -Platelets < 100.000 / mm3
    -Prothrombin time: > 1.25 X ULN
    -Creatinine clearance according to the Cockroft-Gault equation: ? 70 mL/min
    -Any other laboratory abnormality that is judged by the investigator to be clinically relevant
    1.Mujeres embarazadas o en periodo de lactancia.
    2.Pacientes que tengan dolor intenso relacionado con otras causas.
    3.Exposición en los 30 días previos a fármacos que pueden causar neuropatía (como los descritos en la sección 6.2.2 Medicación prohibida).
    4.Trastornos psiquiátricos mayores.
    5.Enfermedad cardiovascular grave o inestable que pudiera comprometer la participación o pudiera ser causa de hospitalización durante el estudio.
    6.Bloqueo auriculoventricular de segundo o tercer grado no corregido con marcapasos o cualquier anomalía clínicamente significativa en el electrocardiograma de 12 derivaciones a juicio del investigador.
    7.Se excluirá a los pacientes que estén tomando las siguientes clases de fármacos y fármacos en concreto cuyo uso no se pueda interrumpir:
    ?benzodiacepinas (excepto somníferos con una semivida corta)
    ?miorrelajantes
    ?esteroides administrados por vía oral
    ?analgésicos de acción central (dextrometorfano, tramadol)
    ?opiáceos
    ?lidocaína o capsaicina de uso tópico
    ?AINE
    ?antiepilépticos distintos a gabapentina y pregabalina
    ?antidepresivos tricíclicos, inhibidores selectivos de la recaptación de serotonina (ISRS) o inhibidores de la recaptación de serotonina y noradrenalina (IRSN)
    ?antagonistas de NMDA
    ?talidomida
    ?óxido nitroso
    ?perfusiones de Ca2+/Mg2+
    En el caso de suspender su administración, estos fármacos requieren un periodo mínimo de lavado de al menos 5 veces su vida media y deberán disminuirse progresivamente de forma adecuada según las instrucciones del prospecto como guía antes de que el paciente entre en el periodo de preinclusión del estudio.
    8.Pacientes que estén tomando gabapentina o pregabalina cuya dosis se haya modificado en el mes previo a la visita de selección.
    9.Antecedentes de cualquier enfermedad grave activa que, en opinión del investigador, pueda comprometer la seguridad del paciente o interferir con las evaluaciones del estudio.
    10.Antecedentes de abuso de drogas o drogodependencia (categorías definidas por el DSM IV) en el último año, exceptuando nicotina y cafeína.
    11.Pacientes que, en los 30 días previos, recibieron tratamiento con un fármaco que no ha recibido la aprobación de las autoridades sanitarias para alguna indicación en el momento de entrar en el estudio.
    12.Antecedentes de gastroparesia grave o cirugía de derivación gástrica.
    13.Tratamiento neurolítico o neuroquirúrgico previo para el dolor neuropático en estudio.
    14.Uso de anestésicos o esteroides inyectados en los 30 días previos a la Visita 1.
    15.Neoplasia maligna en los últimos 2 años.
    16.Antecedentes conocidos de una prueba positiva para anticuerpos (frente a HIV) o infección conocida por VIH.
    17.Antecedentes conocidos de serología positiva para hepatitis B o C sugestiva de infección aguda o crónica activa.
    18.Incapacidad para cumplir con los procedimientos del estudio.
    19.Pacientes con las siguientes anomalías en los valores analíticos:
    ?ALT, AST y GGT > 2 veces el LSN
    ?Neutrófilos < 1.500/mm3
    ?Linfocitos < 1.000/mm3
    ?Hemoglobina < 10 g/dl
    ?Plaquetas < 100.000/mm3
    ?Tiempo de protrombina: > 1,25 veces el LSN
    ?Aclaramiento de creatinina según la fórmula de Cockroft-Gault: ? 70 ml/min
    ?Cualquier otra anomalía analítica que el investigador considere clínicamente relevante.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    ? Time specific change from baseline to day 28 in mean pain intensity in
    the previous 7 days interval measured by a Numerical Pain Rating Scale
    (NPRS) included in a patient diary (average and worst 24 hour pain
    included in the short form of the Brief Pain Inventory [SF-BPI])
    ? 50%-responder rates at day 7, 14, 21 and 28, defined as the
    proportion of patients with a reduction from baseline of at least 50% of
    the mean 24 hour average pain score in the previous 7 days (measured
    by a NPRS included in a patient diary)
    ? 30%-responder rates at day 7, 14, 21 and 28, defined as the
    proportion of patients with a reduction from baseline of at least 30% of
    the mean 24 hour average pain score in the previous 7 days (measured
    by a NPRS included in a patient diary)
    ? Time specific change from baseline to day 7, 14 and 21 in mean pain
    intensity in the corresponding previous 7 days measured by a NPRS
    included in a patient diary (average and worst 24h hour pain)
    ? Time to onset of sustained therapeutic improvement, defined as first
    day on which patients demonstrated a ?1-point reduction in mean pain
    NPRS score from baseline in patients with a ?30 and ?50% reduction in
    mean pain score at day 28
    ? Percentage of subjects needing rescue medication and amount of
    rescue medication used
    ? Change from baseline to day 28 in short form of McGill Pain
    Questionnaire (SF-MPQ)
    ? Change from baseline to day 7, 14, 21 and 28 in SF-BPI
    ? Change from baseline to day 7, 14, 21 and 28 in Neuropathic Pain
    Symptom Inventory (NPSI)
    ? Change from baseline to day 7, 14, 21 and 28 in allodynia andhyperalgesia, measured by VAS after stimulus (brushing and pinprick)
    ? Assessment of post-treatment pain by measurement of efficacy
    endpoints at day 35
    ? Change from baseline to day 28 in SF-36
    ? Patient Global Impression of Change at day 28
    Eficacia
    ?Cambio específico en el tiempo desde el inicio del estudio al día 28 en la media de la intensidad del dolor en el intervalo de los 7 días previos, determinado según la escala numérica de valoración del dolor (NPRS) incluida en el diario del paciente (promedio de la intensidad máxima y media del dolor de 24 horas incluido en el cuestionario breve para la evaluación del dolor (edición corta) [SF-BPI]).
    ?Tasa de respondedores-50% los días 7, 14, 21 y 28, definida como la proporción de pacientes con una reducción respecto al inicio del estudio de al menos el 50% en la media de la puntuación del dolor promedio de 24 horas en los 7 días previos (determinado mediante una escala NPRS incluida en el diario del paciente).
    ?Tasa de respondedores-30% los días 7, 14, 21 y 28, definida como la proporción de pacientes con una reducción respecto al inicio del estudio de al menos el 30% en la media de la puntuación del dolor promedio de 24 horas en los 7 días previos (determinado mediante una escala NPRS incluida en el diario del paciente).
    ?Cambio específico en el tiempo desde el periodo basal hasta el día 7, 14 y 21 en la media de la intensidad del dolor en los últimos 7 días correspondientes a cada período determinada mediante una escala NPRS incluida en el diario del paciente (intensidad máxima y media del dolor de 24 horas).
    ?Tiempo hasta el inicio de una mejoría terapéutica mantenida, definida como el primer día en que los pacientes mostraron una reducción ? 1 punto en la media de la puntuación del dolor según la escala NPRS con respecto a la puntuación basal los pacientes con una reducción ? 30% y ? 50% en la media de la puntuación del dolor el día 28.
    ?Porcentaje de pacientes que necesitan medicación de rescate y cantidad de medicación de rescate utilizada.
    ?Cambio desde el inicio del estudio al día 28 en el cuestionario de McGill sobre el dolor - versión abreviada (SF-MPQ).
    ?Cambio desde el inicio del estudio a los días 7, 14, 21 y 28 en el SF-BPI.
    ?Cambio desde el inicio del estudio a los días 7, 14, 21 y 28 en el inventario de síntomas de dolor neuropático (NPSI).
    ?Cambio desde el inicio del estudio a los días 7, 14, 21 y 28 en la alodinia e hiperalgesia, determinadas mediante la escala visual analógica (EVA) tras un estímulo (tocar la piel con un cepillo y pinchazo).
    ?Cambio desde el inicio del estudio a los días 7, 14, 21 y 28 en la zona de dolor, alodinia e hiperalgesia.
    ?Evaluación del dolor después del tratamiento mediante la determinación de los criterios de valoración de la eficacia el día 35.
    ?Cambio desde el inicio del estudio al día 28 en el SF-36.
    ?Escala de impresión global del cambio según el paciente el día 28.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 días
    E.5.2Secondary end point(s)
    Safety
    ? Adverse Events (AEs) reported
    ? The percentage of patients reporting one or more AEs
    ? Laboratory tests at screening visit and Day 28 (+ follow up tests if
    necessary)
    ? Vital signs and ECG findings at each visit
    Seguridad
    ?Acontecimientos adversos (AA) notificados.
    ?Porcentaje de pacientes que refieren uno o más AA.
    ?Pruebas analíticas en la visita de selección y el día 28 (+ pruebas de seguimiento en caso necesario).
    ?Resultados de ECG y constantes vitales en cada visita.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    28 días
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned12
    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
    Last patient last visit
    última visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    Expected normal treatment
    Tratamiento de acuerdo a la práctica clínica habitual
    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 Decision2012-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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