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    Summary
    EudraCT Number:2012-004359-35
    Sponsor's Protocol Code Number:R331333PAI3037
    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:2014-05-20
    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 number2012-004359-35
    A.3Full title of the trial
    An evaluation of the efficacy and safety of tapentadol oral solution in the treatment of post-operative acute pain requiring opioid treatment in pediatric subjects aged from birth to less than 18 years old.
    Evaluación de la eficacia y seguridad de tapentadol solución oral en el tratamiento del dolor agudo posoperatorio que requiere tratamiento opioide en pacientes pediátricos con edades desde el nacimiento hasta menos de 18 años.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at Tapentadol Oral Solution in Children and Adolescents in pain after Surgery
    Estudio para analizar tapentadol solución oral en niños y adolescentes en el dolor después de la cirugía
    A.4.1Sponsor's protocol code numberR331333PAI3037
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02081391
    A.5.4Other Identifiers
    Name:INDNumber:108134
    Name:GrünenthalNumber:KF5503/65
    Name:DepomedNumber:R331333PAI3037
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/279/2013
    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.4.1Name of organisation providing supportDepomed Inc.
    B.4.2CountryUnited States
    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 pointGrünenthal 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+49241569 3223
    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 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 nameTapentadol 4 mg/mL oral solution
    D.3.2Product code CG5503/R331333
    D.3.4Pharmaceutical form Oral solution
    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 INNTapentadol hydrochloride
    D.3.9.1CAS number 175591-09-0
    D.3.9.2Current sponsor codeCG5503/R331333
    D.3.9.3Other descriptive nameTAPENTADOL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB32145
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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.IMP: 2
    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 nameTapentadol 20 mg/mL oral solution
    D.3.2Product code CG5503/R331333
    D.3.4Pharmaceutical form Oral solution
    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 INNTapentadol hydrochloride
    D.3.9.1CAS number 175591-09-0
    D.3.9.2Current sponsor codeCG5503/R331333
    D.3.9.3Other descriptive nameTAPENTADOL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB32145
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboOral solution
    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
    The management of acute postoperative pain in hospitalized paediatric patients.
    El manejo del dolor postoperatorio agudo en pacientes pediátricos hospitalizados
    E.1.1.1Medical condition in easily understood language
    A study to look at Tapentadol Oral Solution in Children and Adolescents in pain after Surgery
    Estudio para analizar tapentadol solución oral en niños y adolescentes en el dolor después de la cirugía
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10036236
    E.1.2Term Postoperative pain relief
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10054711
    E.1.2Term Postoperative pain
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic medication (morphine equivalents in mg/kg body weight) used within the first 24 hours after first IMP intake.
    Evaluar la eficacia de tapentadol solución oral, en función de la cantidad total de analgésicos opioides suplementarios utilizados en un periodo de 24 horas tras iniciar el tratamiento con el medicamento en investigación.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of tapentadol oral solution using multiple subjective and objective measures of the subject's response to treatment.
    Evaluar la eficacia de tapentadol solución oral utilizando múltiples determinaciones subjetivas y objetivas de la respuesta del paciente al tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent, and if applicable assent, given according to local regulations.
    2. Male or female subject aged from birth to less than 18 years.
    3. A female subject must be pre-menarchal, or surgically incapable of childbearing, or sexually abstinent, or if a female subject is sexually active, then she must be practicing an effective method of birth control (e.g., prescription hormonal contraceptives, intra-uterine devices used according to the product's instruction, double-barrier methods) before trial entry and throughout the trial.
    4. female subject must have a negative urine pregnancy test if aged 12 years or older, or is post-menarchal, or is sexually active.
    5. Subject has undergone surgery (other than brain surgery or gastrointestinal surgery expected to affect the absorption of tapentadol [in the investigator's judgment]) that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment for at least 24 hours after allocation/randomization to IMP. Subjects must remain hospitalized until the End of Treatment Visit
    6. Subject has received post-operative morphine or hydromorphone by NCA/PCA, with or without a background infusion of the same opioid, according to standard of care prior to allocation/randomization to IMP and subject is expected to require this morphine or hydromorphone by NCA/PCA after starting IMP.
    7. Subject is able to tolerate liquids at the time of allocation/ randomization to IMP.
    1. Consentimiento informado y si procede asentimiento, otorgado conforme a la normativa local.
    2. Paciente de ambos sexos con una edad desde el nacimiento hasta menos de 18 años.
    3. Las chicas deben ser premenárquicas, o estar quirúrgicamente estériles, o abstenerse de mantener relaciones sexuales, o si una chica es sexualmente activa, debe utilizar un método anticonceptivo eficaz (p. ej.: anticonceptivos hormonales de prescripción, dispositivos intrauterinos utilizados conforme a las instrucciones del producto, métodos de doble barrera) antes de entrar en el ensayo y durante todo el ensayo.
    4. Las chicas de 12 años o más, o posmenárquicas, o sexualmente activas deben dar negativo en una prueba de embarazo en orina.
    5. El paciente se ha sometido a cirugía (excepto cirugía cerebral o cirugía gastrointestinal que se espera que afecte a la absorción de tapentadol [según criterio del investigador]) que, en opinión del investigador, producirá con toda certeza un dolor de moderado a severo que requerirá tratamiento opioide durante al menos 24 horas tras la asignación/aleatorización al MI. Los pacientes deben permanecer hospitalizados hasta la visita de fin de tratamiento.
    6. El paciente ha recibido morfina o hidromorfona posoperatorias controlada por el/la enfermero/a o controlada por el paciente, con o sin una perfusión de fondo del mismo opioide, conforme a las normas asistenciales antes de la asignación/aleatorización al MI y se espera que el paciente requiera esta morfina o hidromorfona controlada por el/la enfermero/a o controlada por el paciente tras comenzar el MI.
    7. El paciente es capaz de tolerar líquidos en el momento de la asignación/aleatorización al MI.
    E.4Principal exclusion criteria
    1. Subject, parent or the legal representative is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site, or family member of the employees or the investigator.
    2. Subject has been previously exposed to tapentadol.
    3. Subject has received an experimental drug or used an experimental medical device within 28 days before allocation/randomization to IMP, or within a period less than 10 times the drug's half-life, whichever is longer.
    4. Subject has a history or current condition of any one of the following:
    - Non-febrile seizure disorder.
    - Epilepsy.
    - Serotonin syndrome.
    - Traumatic or hypoxic brain injury, brain contusion, stroke, transient ischemic attack, intracranial hematoma, post-traumatic amnesia, brain neoplasm, or episode(s) of unconsciousness of more than 24 hours.
    5. Subject has a history or current condition of any one of the following:
    - Moderate to severe renal or hepatic impairment.
    - Abnormal pulmonary function or clinically relevant respiratory disease (e.g., acute or severe bronchial asthma, hypercapnia).
    6. Subject has a concomitant disease or disorder (e.g., endocrine, metabolic, neurological, psychiatric, infection, febrile seizure, paralytic ileus) that in the opinion of the investigator may affect or compromise subject safety during the trial participation.
    7. Subject has history of suicidal ideation or behavior.
    8. Subject is obese, e.g., BMI above the 97th percentile for children based on the World Health Organization growth charts.
    9. Subject has a clinically relevant history of hypersensitivity, allergy, or contraindication to the supplemental opioid analgesic medication or tapentadol, or the excipients, or naloxone.
    10. Subject is not able to understand and comply with the protocol as appropriate for the age of the subject or subject is cognitively impaired in the investigator's judgment such that they cannot comply with the protocol.
    11. Subject has a history of alcohol and/or substance abuse in the investigator's judgment based on subject?s history and physical examination.
    12. Subject is taking prohibited concomitant medication.
    13. Subject has received a long-acting opioid for the treatment of pain following surgery within 6 hours of allocation/randomization to IMP.
    14. Subject has clinically relevant (in the investigator's judgment) abnormal values for clinical chemistry or hematology (local laboratory sample taken after surgery).
    A subject is excluded if the:
    - Aspartate transaminase or alanine transaminase is >3-times upper limit of normal.
    - Total bilirubin is >2-times upper limit of normal (except if the cause is due to Gilbert?s syndrome).
    - Glomerular filtration rate <60 mL/min (calculated according to Schwartz et al. 1984).
    15. Subject has:
    - Clinically relevant abnormal ECG.
    - Signs of pre-excitation syndrome.
    - Brugada's syndrome.
    - QT or QTc interval >470 ms for children aged 6 years to less than 18 years old.
    - QT or QTc interval >460 ms for children aged from birth to less than 6 years old.
    16. Peri- or post-operative analgesia supplied by a continuous regional technique (i.e., nerve block) or subject controlled epidural analgesia that was terminated less than 6 hours before allocation/randomization to IMP.
    17. Subject has post-operative clinically unstable systolic and diastolic blood pressure, heart rate, respiratory depression, or clinically unstable upper or lower airway conditions (in the investigator's judgment), or a saturation of peripheral oxygen (SpO2) <92% at the time of randomization (allocation/randomization to IMP).
    18. Female subject is breast-feeding a child.
    1. El paciente, el padre/la madre o el representante legal es un empleado del investigador o del centro del ensayo, con implicación directa en el ensayo propuesto u otros ensayos bajo la dirección de dicho investigador o centro del ensayo, o es un familiar de los empleados o del investigador.
    2. El paciente ha sido previamente expuesto a tapentadol.
    3. El paciente ha recibido un medicamento experimental o ha utilizado un dispositivo médico experimental en los 28 días anteriores a la asignación/aleatorización al MI, o dentro de un periodo inferior a 10 veces la semivida del medicamento, el que sea mayor.
    4. El paciente tiene antecedentes o actualmente cualquiera de las siguientes enfermedades:
    - Trastorno de crisis convulsivas afebriles.
    - Epilepsia.
    - Síndrome serotoninérgico.
    - Lesión cerebral traumática o hipóxica, contusión cerebral, ictus, ataque isquémico transitorio, hematoma intracraneal, amnesia postraumática, neoplasia cerebral o episodio(s) de pérdida de conocimiento durante más de 24 horas.
    5. El paciente tiene antecedentes o actualmente cualquiera de las siguientes enfermedades:
    - Insuficiencia renal o hepática moderada o grave.
    - Función pulmonar anormal o enfermedad respiratoria clínicamente relevante (p. ej.: asma bronquial aguda o grave, hipercapnia).
    6. El paciente tiene una enfermedad o trastorno concomitante (p. ej.: endocrinológico, metabólico, neurológico, psiquiátrico, infección, crisis convulsiva febril, íleon paralítico) que en la opinión del investigador pueda afectar o comprometer la seguridad del paciente durante la participación en el ensayo.
    7. El paciente tiene antecedentes de ideación o conducta suicida.
    8. El paciente es obeso, p. ej.: IMC por encima del percentil 97 para niños en las tablas de crecimiento de la Organización Mundial de la Salud (ver sección 19.9).
    Estandarización de la población del ensayo.
    9. El paciente tiene una historia clínicamente relevante de hipersensibilidad, alergia o contraindicación a los analgésicos opioides suplementarios o a tapentadol o a los excipientes (ver el manual del investigador), o a naloxona.
    10. El paciente no es capaz de entender y cumplir con el protocolo conforme a la edad del paciente o, a criterio del investigador, el paciente presenta un deterioro cognitivo que le impide cumplir con el protocolo.
    11. El paciente tiene una historia de abuso de alcohol y/o sustancias según criterio del investigador en función de la historia del paciente y la exploración física.
    12. El paciente toma medicamentos concomitantes prohibidos.
    13. El paciente ha recibido un opioide de acción prolongada para el tratamiento del dolor tras la cirugía en las 6 horas anteriores a la asignación/aleatorización al MI.
    14. El paciente tiene valores anómalos clínicamente relevantes (según criterio del investigador) de bioquímica clínica o hematología (muestra del laboratorio local recogida después de la cirugía).
    Un paciente quedará excluido si:
    - Aspartato-aminotransferasa o alanina-aminotransferasa >3 veces el límite superior de la normalidad.
    - Bilirrubina total >2 veces el límite superior de la normalidad (excepto si se debe al síndrome de Gilbert).
    - Velocidad de filtración glomerular <60 ml/min (calculada conforme a Schwartz et al. 1984).
    15. El paciente tiene:
    - ECG anómala clínicamente relevante.
    - Signos de síndrome de preexcitación.
    - Síndrome de Brugada.
    - Intervalo QT o QTc >470 ms en niños de 6 años a menos de 18 años.
    - Intervalo QT o QTc >460 ms en niños con edades desde el nacimiento hasta menos de 6 años.
    16. Analgesia perioperatoria o posoperatoria administrada mediante técnica regional continua (es decir, bloqueo nervioso) o analgesia epidural controlada por el paciente que finalizó menos de 6 horas antes de la asignación/aleatorización al MI.
    17. El paciente tiene tensión arterial sistólica y diastólica, frecuencia cardiaca o depresión respiratoria posoperatorias clínicamente inestables, o afecciones clínicamente inestables en las vías respiratorias altas o bajas (según criterio del investigador), o una saturación de oxígeno periférico (SpO2) <92 % en el momento de la aleatorización (asignación/aleatorización al MI).
    18. La paciente se encuentra amamantando a un bebé.
    E.5 End points
    E.5.1Primary end point(s)
    The total amount of supplemental opioid analgesic medication (morphine equivalents in mg/kg body weight) used after first IMP intake.
    La cantidad total de analgésicos opioides suplementarios (equivalentes de morfina en mg/kg de peso corporal) utilizados tras la primera administración del MI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    EU: 24 hours
    US: 12 hours
    UE: 24 hours
    EE.UU.: 12 hours
    E.5.2Secondary end point(s)
    1. The total amount of supplemental opioid analgesic medication received assesed in 12 hour intervals from 24 hours to 96 hours after the first dose of IMP.
    2. The total amount of non-opioid analgesics used.
    3. Palatability and acceptability of the IMP.
    4. Changes from baseline in pain intensity.
    5. Clinician Global Impression of Change.
    6. Patient Global Impression of Change.
    7. Time to first and time to second NCA/PCA after first dose of IMP.
    8. Time to first dose of IMP until IMP treatment discontinuation due to lack of efficacy.
    9. Safety
    - Percentage of subjects with TEAEs.
    - Percentages of subjects who develop abnormal:
    - Vital signs.
    - Laboratory parameters.
    - 12-lead ECG parameters.
    - Changes from baseline in vital signs parameters.
    - Changes from baseline in safety laboratory parameters.
    - Changes from baseline in 12-lead ECG parameters.
    - Percentage of subjects discontinuing the trial due to TEAEs and drug-related adverse events.
    - Suicidal ideation/behavior in subjects aged 6 years or older using the C-SSRS scores before IMP and at the end of the trial.
    - Sedation scores.
    Los criterios secundarios de valoración de eficacia son:
    - La cantidad total de analgésicos opioides suplementarios recibidos, evaluados a intervalos de 12 horas a partir de las 24 horas hasta las 96 horas tras la primera dosis del MI.
    - La cantidad total de analgésicos no opioides utilizados.
    - Palatabilidad y aceptabilidad del MI.
    - Cambios desde el valor basal en la intensidad del dolor.
    - CGIC por parte del investigador/médico.
    - PGIC por parte del paciente/padre/madre/representante legal.
    - Tiempo hasta la primera y hasta la segunda analgesia controlada por el/la enfermero/a o por el paciente tras la primera dosis del MI.
    - Tiempo desde la primera dosis del MI hasta la suspensión del tratamiento con el MI por falta de eficacia.

    Criterios de valoración de seguridad:
    - Porcentaje de pacientes con RAST.
    - Porcentajes de pacientes con valores anómalos en:
    - Constantes vitales.
    - Parámetros de laboratorio.
    - Parámetros del ECG de 12 derivaciones.
    - Cambios desde el valor basal en los parámetros de constantes vitales.
    - Cambios desde el valor basal en los parámetros de laboratorio de seguridad.
    - Cambios desde el valor basal en los parámetros del ECG de 12 derivaciones.
    - Porcentaje de pacientes que abandonan el ensayo debido a RAST y reacciones adversas asociadas a los medicamentos.
    - Ideación/conducta suicida en pacientes de 6 años o mayores utilizando las puntuaciones en la escala C-SSRS antes del MI y al final del ensayo.
    - Puntuaciones de la sedación
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints:
    12 hours
    24 hours
    up to 96 hours
    Safety endpoints:
    up to Day 14
    Criterios secundarios de valoración de eficacia:
    12 horas
    24 horas
    Hasta las 96 horas

    Criterios de valoración de seguridad:
    Hasta el día 14
    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 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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Austria
    Croatia
    France
    Germany
    Poland
    Spain
    Sweden
    United Kingdom
    United States
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    F.1.1Number of subjects for this age range: 168
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 3
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 6
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 100
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 59
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children of certain young age (determined by local laws) not capable of signing the informed consent form. In this situation, the child will sign and assent form and his/her parent(s) or legal guardian(s) will sign and informed consent form.
    Niños de cierta edad (según la legislación local) incapaces de firmar el documento de consentimiento informado. En esta situación, el niño firmará un documento de asentimiento y su padre/ madre o tutor(es) firmará(n) un consentimiento informado.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 168
    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)
    Children and Adolscents will be treated after their last intake of IMP as per standard of care.
    Tras finalizar la visita de fin de tratamiento (visita 3), los pacientes recibirán asistencia de sus médicos conforme al tratamiento estándar específico del centro en cuestión.
    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 Decision2014-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-14
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