Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35906   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-000347-28
    Sponsor's Protocol Code Number:KF10004/10
    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:2012-07-09
    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 number2012-000347-28
    A.3Full title of the trial
    Efficacy and safety of lidocaine 5% medicated plaster in localized
    chronic post-operative neuropathic pain
    Eficacia y seguridad del apósito adhesivo medicamentoso de lidocaína al 5 % en el dolor neuropático posoperatorio localizado crónico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and tolerability of lidocaine for long-term local nerve pain
    Eficacia y tolerabilidad de la lidocaína para el dolor neuropático localizado crónico
    A.4.1Sponsor's protocol code numberKF10004/10
    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 SponsorGrünenthal GmbH
    B.1.3.4CountryGermany
    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 supportGrünenthal GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrünenthal GmbH
    B.5.2Functional name of contact pointGRT Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressZieglerstr. 6
    B.5.3.2Town/ cityAachen
    B.5.3.3Post code52078
    B.5.3.4CountryGermany
    B.5.4Telephone number+492415693223
    B.5.6E-mailClinical-Trials@grunenthal.com
    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 Versatis 5% medicated plaster
    D.2.1.1.2Name of the Marketing Authorisation holderGrünenthal GmbH
    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 nameLidocaine 5% medicated plaster
    D.3.4Pharmaceutical form Medicated plaster
    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 % (W/W) percent weight/weight
    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.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 placeboMedicated plaster
    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
    moderate to severe localized chronic post-operative neuropathic pain
    dolor postoperatorio neuropático localizado crónico de moderado a severo
    E.1.1.1Medical condition in easily understood language
    long-term local nerve pain
    dolor neuropático localizado crónico
    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 primary objective is to assess the superiority of the analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic post-operative neuropathic pain (PoNP).
    El objetivo principal es evaluar la superioridad del efecto analgésico del apósito adhesivo medicamentoso de lidocaína al 5 % en comparación con placebo en pacientes con dolor neuropático posoperatorio (DNP) localizado crónico de moderado a grave.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of lidocaine 5% medicated plaster on quality of life, allodynia, and other various symptoms of localized neuropathic pain in subjects suffering from moderate to severe localized chronic PoNP.
    To evaluate the safety and tolerability of lidocaine 5% medicated plaster in subjects suffering from moderate to severe localized chronic PoNP.
    ?Evaluar los efectos del apósito adhesivo medicamentoso de lidocaína al 5 % sobre la calidad de vida, la alodinia y otros síntomas diversos del dolor neuropático localizado en pacientes que sufren DNP localizado crónico de moderado a grave.
    ?Evaluar la seguridad y tolerabilidad del apósito adhesivo medicamentoso de lidocaína al 5 % en pacientes que sufren DNP localizado crónico de moderado a grave.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female subjects aged >18 years at Visit 1.
    Subjects having understood the nature of the trial and having given written informed consent.
    Subjects able to communicate meaningfully with investigational site staff, to comply with investigational site staff instructions, to comply with the planned use of the IMPs, to complete the questionnaires, and to use the e-diaries.
    For women of childbearing potential, a negative pregnancy test (sample taken at Visit 1).
    Subjects suffering from moderate to severe localized chronic PoNP following surgery. Localized chronic PoNP is defined as chronic neuropathic pain on the surface of a single cutaneous area neurologically related to the site of surgery and following surgery (e.g., thoracotomy, total knee replacement, cholecystectomy, mastectomy, inguinal hernia repair, varicose vein stripping).
    The surgery leading to PoNP was performed 3 to 36 months prior to Visit 1.
    Pain intensity at Visit 1 (subject?s average pain during the last 24 hours before the Enrollment Visit) of ?4 on the 11 point NRS.
    Localized PoNP present for ?3 months prior to Visit 1.
    Douleur neuropathique 4 (DN4) questionnaire score ?4/10 at Visit 1.
    Size of the affected painful skin area is not larger than the size of 3 plasters.
    Intact skin besides the scar of surgery (absence of skin disease, skin irritation, inflammation or injury, such as active herpes zoster lesions, atopic dermatitis, wounds) in the area where the plasters will be applied.
    Adherence to the restricted use of concomitant treatments.
    Compliance with the use of e-diaries; at least 75% of all NRS entries must be available since Visit 1 (assessed at Visit 2).
    Baseline average pain intensity assessed at Visit 2 (mean of subject?s average pain intensities during the last 24 hours, calculated over the last 7 days of the Enrollment Period) of ?4 on the 11 point NRS
    1.Hombres o mujeres de >18 años en la visita 1.
    2.Pacientes que han entendido la naturaleza del ensayo y que han entregado su consentimiento informado por escrito.
    3.Pacientes capaces de comunicarse correctamente con el personal del centro de investigación, de cumplir las instrucciones del personal del centro de investigación, de cumplir el uso previsto del FI, de cumplimentar los cuestionarios y de utilizar los diarios electrónicos.
    4.Para las mujeres en edad fértil, prueba de embarazo negativa (muestra tomada en la visita 1).
    5.Pacientes que presenten DNP localizado crónico de moderado a grave tras haberse sometido a una cirugía. El DNP localizado crónico se define como el dolor neuropático crónico de una única zona cutánea neurológicamente relacionada con el lugar donde se ha practicado la cirugía y que ha aparecido tras la realización de esta (p. ej., toracotomía, artroplastia total de rodilla, colecistectomía, mastectomía, reparación de hernia inguinal, extirpación de vena varicosa).
    6.La cirugía causante del DNP se realizó de 3 a 36 meses antes de la visita 1.
    7.Intensidad del dolor en la visita 1 (dolor medio del paciente durante las últimas 24 horas antes de la visita de inclusión) de ?4 en la ECN de 11 puntos.
    8.DNP localizado presente durante ?3 meses antes de la visita 1.
    9.Puntuación en el cuestionario sobre dolor neuropático (DN4) ?4/10 en la visita 1.
    10.Extensión de la zona de piel dolorosa afectada no superior al tamaño de 3 apósitos.
    11.Piel sana, excepto la cicatriz de la cirugía (ausencia de enfermedades cutáneas, irritación cutánea, inflamación o lesiones, como las provocadas por un herpes zóster activo, dermatitis atópica, heridas) en la zona donde se aplicarán los apósitos.
    12.Observancia del uso restringido de los tratamientos concomitantes (véase la Sección 10.5).
    13.Cumplimiento del uso de los diarios electrónicos; al menos el 75 % de todas las entradas de la ECN deben estar disponibles desde la visita 1 (se evalúan en la visita 2).
    14.Intensidad media del dolor al inicio del estudio, valorada en la visita 2 (media de las intensidades de dolor medias del paciente durante las últimas 24 horas, calculada durante los últimos 7 días del periodo de inclusión) de ?4 en la ECN de 11 puntos.
    E.4Principal exclusion criteria
    Participation in another trial of IMPs or devices parallel to, or <30 days prior to Visit 1, or previous participation in this trial.
    Any dependency of the subject to the investigator or the trial site, e.g., employees with direct involvement in the proposed trial or in other trials under the direction of this investigator or trial site, as well as family members of the employees or the investigator.
    History of dependency or ?active? drug abuse (alcohol, medication) during the 1 year prior to Visit 1.
    Evidence or history (during the 3 years prior to Visit 1) of neurotic personality or psychiatric illness.
    Pregnant or breastfeeding women or women of childbearing potential who are sexually active without satisfactory contraception.
    Any surgery performed in the 3 months prior to Visit 1, which may affect efficacy or safety assessment, or any surgery scheduled or expected during the trial.
    Clinically significant disease (e.g., acquired immunodeficiency syndrome) or condition that may affect efficacy or safety assessments, or any other reason which, in investigator?s opinion, may preclude the subject?s participation in the trial.
    Any painful procedure planned during the trial that may, in the opinion of the investigator, affect the efficacy or safety assessments.
    History of malignancy (with the exception of neoplasia related to the trial indication) within 2 years prior to Visit 1.
    Pending litigation due to chronic pain or disability.
    Other painful conditions in the area of PoNP of infectious or non infectious, inflammatory, or neuropathic causes, or conditions representing a complication of the previous surgical procedure which may affect efficacy or safety assessments.
    For subjects with PoNP related to a surgery due to neoplasia: suspected residual neoplasia or metastases.
    Presence of total anesthesia in the cutaneous area neurologically related to the site of surgery (test performed at Visit 1).
    Hypersensitivity to the IMP, its excipients, or anesthetics of the amide type.
    Severe cardiac impairment, e.g., New York Heart Association Class ?III, myocardial infarction in the 6 months prior to Visit 1, and/or unstable angina pectoris.
    Any former use of topical lidocaine in the area of localized chronic PoNP.
    Any use of Class I anti arrhythmic medicinal products (e.g., tocainide, mexiletine, flecainide, and intravenous lidocaine), or local anesthetics containing lidocaine or ketamine in the 3 days prior to Visit 1 or planned during the trial.
    Known severe renal impairment or a glomerular filtration rate/creatinine clearance <30 mL/min. The Cockroft and Gault formula will be used to calculate the creatinine clearance (sample taken at Visit 1).
    Known severe hepatocellular insufficiency.
    1.Participación en otro ensayo con FI o dispositivos que se esté realizando en paralelo a este ensayo o <30 días antes de la visita 1, o participación previa en este ensayo.
    2.Cualquier dependencia del paciente respecto al investigador o el centro del ensayo, p. ej., empleados con implicación directa en el ensayo propuesto o en otros ensayos dirigidos por este investigador o centro del ensayo, así como familiares de los empleados del investigador.
    3.Antecedentes de dependencia o drogadicción "activa" (alcohol, medicación) durante el año anterior a la visita 1.
    4.Pruebas o antecedentes (durante los 3 años anteriores a la visita 1) de personalidad neurótica o enfermedad psiquiátrica.
    5.Mujeres embarazadas o en periodo de lactancia o mujeres en edad fértil sexualmente activas que no utilicen un método anticonceptivo adecuado.
    6.Cualquier intervención quirúrgica realizada en los 3 meses anteriores a la visita 1 que pueda afectar a la valoración de la eficacia o la seguridad, o cualquier intervención quirúrgica programada o prevista durante el ensayo.
    7.Enfermedad clínicamente significativa (p. ej., síndrome de inmunodeficiencia adquirida) o enfermedad que pueda afectar a las evaluaciones de eficacia o seguridad, o cualquier otro motivo que, a juicio del investigador, pueda impedir la participación del paciente en el ensayo.
    8.Cualquier procedimiento doloroso planificado durante el ensayo que, a juicio del investigador, pueda afectar a las valoraciones de eficacia o seguridad.
    9.Antecedentes de neoplasias malignas (a excepción de la neoplasia asociada a la indicación del ensayo) en el periodo de los 2 años anteriores a la visita 1.
    10.Litigios pendientes debido a dolor crónico o discapacidad.
    11.Otras afecciones dolorosas en la zona del DNP de origen infeccioso o no infeccioso, inflamatorio o neuropático, o afecciones que representen una complicación de la intervención quirúrgica previa que puedan afectar a las valoraciones de eficacia o seguridad.
    12.En el caso de pacientes con DNP relacionado con una intervención quirúrgica debida a una neoplasia: sospecha de neoplasia residual o metástasis.
    13.Presencia de anestesia total en la zona cutánea neurológicamente relacionada con el lugar donde se ha practicado la cirugía (prueba realizada en la visita 1).
    14.Hipersensibilidad al FI, a sus excipientes o a los anestésicos de tipo amida.
    15.Insuficiencia cardiaca grave, p. ej., clase ?III de la New York Heart Association, infarto de miocardio en los 6 meses anteriores a la visita 1 y/o angina de pecho inestable.
    16.Cualquier uso anterior de lidocaína tópica en la zona del DNP localizado crónico.
    17.Cualquier uso de fármacos antiarrítmicos de clase I (p. ej., tocainida, mexiletina, flecainida y lidocaína intravenosa) o anestésicos locales que contengan lidocaína o ketamina en los 3 días anteriores a la visita 1 o planificado durante el ensayo.
    18.Insuficiencia renal grave conocida o índice de filtración glomerular/aclaramiento de creatinina <30 ml/min. Se utilizará la fórmula de Cockroft y Gault para calcular el aclaramiento de creatinina (muestra tomada en la visita 1).
    19.Insuficiencia hepatocelular grave conocida.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change from baseline of recorded average pain intensity values during the last 24 hours, averaged over the 7 days of Week 12 of the Double-blind Treatment Period.
    The baseline value for the primary endpoint is defined as the calculated mean of the average pain values during the last 24 hours for the last 7 days of the Enrollment Period.
    El criterio principal de valoración de la eficacia es el cambio, desde el inicio del estudio, de los valores de intensidad media del dolor registrados durante las últimas 24 horas, promediados durante los 7 días de la semana 12 del periodo de tratamiento doble ciego.
    El valor basal para el criterio de valoración principal se define como la media calculada de los valores de dolor medio durante las últimas 24 horas de los últimos 7 días del periodo de inclusión.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days of Week 12 of the Double-blind Treatment Period
    7 días de la semana 12 del periodo de tratamiento doble ciego.
    E.5.2Secondary end point(s)
    1) Mean pain intensity and mean pain intensity change from baseline based on the average pain intensity during the last 24 hours, calculated over the last 28 days (4 weeks) and 84 days (12 weeks) of the Double blind Treatment Period.
    Timepoint(s) of evaluation of this endpoint: last 28 days (4 weeks) and 84 days (12 weeks) of the Double blind Treatment Period
    2) Mean pain intensity and mean pain intensity change from baseline based on the current pain intensity before plaster removal, calculated over the last 7 days, 28 days (4 weeks), and 84 days (12 weeks) of the Double blind Treatment Period.
    Timepoint(s) of evaluation of this endpoint: last 7 days, 28 days (4 weeks), and 84 days (12 weeks) of the Double blind Treatment Period
    3) Weekly mean pain intensities and weekly mean pain intensity change from baseline based on average pain intensity during the last 24 hours, and current pain intensity before plaster removal, respectively, calculated for each of the 12 weeks of the Double blind Treatment Period.
    Timepoint(s) of evaluation of this endpoint: each of the 12 weeks of the Double blind Treatment Period
    4) Responder rates (thresholds of 30% and 50% improvement compared to baseline) based on average pain intensity values during the last 24 hours at the end of the Double blind Treatment Period. All discontinued subjects will be considered non-responders except for those who do not require pain treatment any more due to absence of pain.
    Timepoint(s) of evaluation of this endpoint: the last 24 hours at the end of the Double blind Treatment Period
    5) Total score of the painDETECT Pain Questionnaire and the changes from baseline during the Double blind Treatment Period.
    Timepoint(s) of evaluation of this endpoint: Visit 3, 4 and 5 of the Double blind Treatment Period
    6) Pain intensity from mechanical dynamic allodynia (brush) testing and change from baseline.
    Timepoint(s) of evaluation of this endpoint: Visit 3, 4 and 5 of the Double blind Treatment Period
    7) Anxiety and depression scores of HADS and changes from baseline.
    Timepoint(s) of evaluation of this endpoint: Visit 5 of the Double blind Treatment Period
    8) Rating of global improvement and satisfaction with treatment according to PGIC using a 7 point verbal rating scale.
    Timepoint(s) of evaluation of this endpoint: Visit 5 of the Double blind Treatment Period
    9) Total score of quality of life by means of EQ 5D and change from baseline.
    Timepoint(s) of evaluation of this endpoint: Visit 5 of the Double blind Treatment Period
    10) Total score in quality of sleep using CPSI and change from baseline
    Timepoint(s) of evaluation of this endpoint: Visit 5 of the Double blind Treatment Period
    ?Intensidad media del dolor y cambio en la intensidad media del dolor desde el inicio del estudio utilizando como base la intensidad media del dolor durante las últimas 24 h, calculada durante los últimos 28 días (4 sem.) y 84 días (12 sem.) del periodo de tratamiento doble ciego.
    ?Intensidad media del dolor y cambio en la intensidad media del dolor desde el inicio del estudio utilizando como base la intensidad del dolor existente antes de la retirada del apósito, calculada durante los últimos 7 días, 28 días (4 semanas) y 84 días (12 semanas) del periodo de tratamiento doble ciego.
    ?Intensidades medias semanales del dolor y cambio en la intensidad media semanal del dolor desde el inicio del estudio utilizando como base la intensidad media del dolor durante las últimas 24 horas y la intensidad del dolor actual antes de la retirada del apósito, respectivamente, calculadas para cada una de las 12 semanas del periodo de tratamiento doble ciego.
    ?Tasas de pacientes con respuesta (umbrales de mejora del 30 % y del 50 % respecto al inicio del estudio) basadas en los valores de intensidad media del dolor durante las últimas 24 horas al final del periodo de tratamiento doble ciego. Todos los pacientes que abandonen el tratamiento del ensayo se considerarán como pacientes que no han respondido al tratamiento, excepto en el caso de aquellos que no vuelvan a requerir tratamiento debido a la desaparición del dolor.
    ?Puntuación total del cuestionario sobre evaluación del dolor painDETECT y los cambios respecto al inicio del estudio durante el periodo de tratamiento doble ciego.
    ?Intensidad del dolor según las pruebas de alodinia mecánica dinámica (con cepillado) y cambios respecto al inicio del estudio.
    ?Puntuaciones de ansiedad y depresión del HADS y cambios respecto al inicio del estudio.
    ?Valoración de la mejora y satisfacción general con el tratamiento según la PGIC, utilizando una escala de puntuación verbal de 7 puntos.
    ?Puntuación total de la calidad de vida mediante el cuestionario EQ 5D y cambios respecto al inicio del estudio.
    ?Puntuación total de la calidad del sueño utilizando el cuestionario CPSI y cambios respecto al inicio del estudio.
    .Puntuación de la evaluación de este objetivo: visita 5 del periodo de tratamiento del doble ciego
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see section E.5.2 (timepoint is given under listed secondary end point).
    Por favor ver sección E 5.2 (puntuación facilitada bajo la lista de la variable secundaria)
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Chile
    Colombia
    Croatia
    Russian Federation
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 310
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 360
    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)
    n.a.
    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 Decision2012-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-21
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA