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    Summary
    EudraCT Number:2014-000499-24
    Sponsor's Protocol Code Number:200722
    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:2014-12-16
    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 number2014-000499-24
    A.3Full title of the trial
    Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants Born to Mothers Participating in Retosiban Treatment Studies
    Estudio de seguimiento para evaluar la seguridad y los resultados a largo plazo en lactantes nacidos de madres que participaron en los estudios de tratamiento con retosibán
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to monitor the safety of the medications used in the preterm labor study by collecting information on the health and development of the child after child's mother participated in a retosiban study for preterm labor during the child's mother's pregnancy.
    El objetivo de este estudio es evaluar la seguridad de los medicamentos utilizados en el estudio de parto pretérmino recogiendo información sobre la salud y el desarrollo de los niños tras haber participado la madre en un estudio con retosibán para el parto pretérmino durante el embarazo.
    A.3.2Name or abbreviated title of the trial where available
    Follow-Up Study to Assess Long-Term Safety of Infants exposed to Retosiban
    Estudio de seguimiento para evaluar la seguridad a largo plazo en niños expuestos a Retosibán
    A.4.1Sponsor's protocol code number200722
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/201/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development Limited
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Limited
    B.5.2Functional name of contact pointRobert Stocken
    B.5.3 Address:
    B.5.3.1Street AddressStockley Park West, 1-3 Ironbridge road
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number900834223
    B.5.5Fax number/
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 nameRetosiban
    D.3.2Product code GSK221149
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRetosiban
    D.3.9.1CAS number 820957-38-8
    D.3.9.2Current sponsor codeGSK 221149A
    D.3.9.4EV Substance CodeSUB29510
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 RoleComparator
    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 Tractocile
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Pharmaceuticals A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATOSIBAN
    D.3.9.1CAS number 90779-69-4
    D.3.9.3Other descriptive nameTractocile
    D.3.9.4EV Substance CodeSUB05601MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Preterm labour and improve neonatal health.
    Parto pretérmino y mejora de la salud neonatal.
    E.1.1.1Medical condition in easily understood language
    Preterm labor and the health and development of the child after the child´s mother participated in a retosiban study for preterm labor during mother?s pregnancy.
    Parto pretérmino y la salud y desarrollo del niño después que la madre participase en un estudio de retosiban para el parto pretérmino durante el embarazo.
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10036595
    E.1.2Term Premature delivery
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study objective is to assess the safety and outcomes in infants who were exposed to retosiban or comparator in the Phase III treatment studiess.
    Specific objectives include the following:
    *To characterize the clinical safety in terms of infant morbidity and mortality in infants exposed to retosiban or comparator
    *To characterize the clinical safety in terms of neurodevelopment in infants exposed to retosiban or comparator
    *To characterize parental productivity loss related to a sick child and infant resource utilization in terms of hospital admissions, length of stay, emergency room/urgent care (ER/UC) visits, surgical procedures, and referral to specialty care or therapy visits for infants exposed to retosiban or comparator
    El objetivo del estudio es evaluar los resultados y la seguridad en los lactantes que estuvieron expuestos a retosibán o a un fármaco de comparación en los estudios de fase III de tratamiento.
    Los objetivos específicos son los siguientes:
    -Caracterizar la seguridad clínica en términos de morbilidad y mortalidad en los lactantes expuestos a retosibán o al fármaco de comparación
    - Caracterizar la seguridad clínica en términos de desarrollo neurológico en los lactantes expuestos a retosibán o al fármaco de comparación
    - Caracterizar la pérdida de productividad parental relacionada con la enfermedad del niño y la utilización de recursos en términos de número de hospitalizaciones, duración de la estancia, visitas al servicio de urgencias o cuidados críticos, intervenciones quirúrgicas y derivaciones a consultas de especialistas o de tratamiento, en los lactantes expuestos a retosibán o al fármaco de comparación
    E.2.2Secondary objectives of the trial
    Not Applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Infants eligible for enrollment in the study must meet all of the following criteria:
    1.Mother is randomly assigned and dosed (retosiban or comparator) in 1 of the Phase III retosiban clinical studies.
    2.Infant is alive at 28 days post EDD.
    3.Written informed consent is obtained from the parent(s) or legal guardian(s) of the infant. The parent/legal guardian of participants aged 12 to 17 years must also provide written agreement for the infant to participate in the study where required by applicable regulatory and country or state requirements.
    Podrán participar en el estudio los sujetos que cumplan todos los criterios siguientes:
    1. A la madre se le ha asignado aleatoriamente y administrado un tratamiento (retosibán o el fármaco de comparación) en uno de los estudios clínicos de fase III con retosibán.
    2. El lactante sigue con vida 28 días después de la fecha estimada del parto.
    3. Se ha obtenido el consentimiento informado por escrito de los padres o tutores legales del niño. Los padres o tutores legales de las madres de 12 a 17 años otorgarán también consentimiento por escrito para la participación del lactante en el estudio cuando así lo exija la normativa vigente en el país o localidad.
    E.4Principal exclusion criteria
    All infants who meet the inclusion criteria will be eligible to enroll in the study. There are no formal exclusion criteria for participation.
    Todos los lactantes que cumplan los criterios de inclusión serán elegibles para participar en el estudio. No hay criterios formales de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    Morbidity and mortality endpoints:
    *Proportion of infants with newly diagnosed (after 28 days post EDD) chronic medical conditions by type of condition will be recorded and include the following:
    *Respiratory conditions
    *Neurological conditions
    *Sensory conditions
    *Gastrointestinal conditions
    *Cardiovascular conditions
    *Renal conditions
    *Growth parameters
    *Proportion of infants with newly diagnosed (after 28 days post EDD) congenital anomalies
    *Proportion of neonatal and infant deaths after 28 days post EDD and until the end of the study
    Criterios de valoración de la morbilidad y la mortalidad:
    Se recogerán la proporción de lactantes con trastornos crónicos de diagnóstico reciente (después del día 28 de la fecha estimada de parto (FEP)), distribuidos por las siguientes categorías:
    - Trastornos respiratorios
    - Trastornos neurológicos
    - Trastornos sensoriales
    - Trastornos digestivos
    - Trastornos cardiovasculares
    - Trastornos renales
    - Parámetros de crecimiento
    - Proporción de lactantes con anomalías congénitas de diagnóstico reciente (a partir del día 28 después de la FEP).
    -Tasa de muertes neonatales y de lactantes ocurridas desde el día 28 después de la FEP y hasta el final del estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    collection of neonatal morbidity data and will occur at 28 days after the estimated date of delivery (EDD) and the infant's parent/legal guardian will be asked to complete a Child Health Inventory at 2, 6, 9, 12, 15, 18, 21, and 24 months of the child´s chronological age
    La colección de datos de morbilidad neonatal se evaluaran a los 28 días de la fecha estimada del parto (FEP) y a los padres del lactante/tutores legales se les pedirá que cumplimenten un Inventario de Salud Infantil a los 2, 6, 9, 12, 15, 18, 21 y 24 meses de edad cronológica del niño.
    E.5.2Secondary end point(s)
    Neurodevelopment endpoints:
    *Neurodevelopment endpoints assessed at ages 9, 18, and 24 months, corrected for prematurity:
    *Proportion of infants with an ASQ-3 score in the black zone in any domain
    *Proportion of infants with an ASQ-3 score in the black zone for gross motor skills
    *Proportion of infants with an ASQ-3 score in the black zone for fine motor skills
    *Proportion of infants with an ASQ-3 score in the black zone for communication
    *Proportion of infants with an ASQ-3 score in the black zone for problem solving
    *Proportion of infants with an ASQ-3 score in the black zone for personal-social skills
    *Proportion of infants referred for developmental evaluation (using BSID III)
    *Proportion of infants with a BSID-III score <2 SDs below the mean score for the cognitive impairment (<70)
    *Proportion of infants with BSID-III score <2 SDs below the mean score for the gross motor scale (<70)
    *Proportion of infants with BSID-III score <2 SDs below the mean score for the fine motor scale (<70)
    *Proportion of infants with a BSID-III score <2 SDs below the mean score for the language scale (<70)
    *Proportion of infants referred for an additional behavioral assessment using the CBCL/1.5-5 and M-CHAT-R/F
    *Proportion of infants with a CBCL/1.5-5 score at or above the 97th percentile for a subset of prespecified questions that relate to attention and hyperactivity problems
    *Proportion of infants indicated as needing further evaluation after completion of the M-CHAT-R/F
    *Proportion of infants referred for neurological evaluation to determine diagnosis of cerebral palsy
    *Proportion of infants with at least 1 of the following indicators of neurodevelopmental impairment at the end of the study:
    *Hearing impaired, uncorrected even with aids
    *Blindness in 1 or both eyes, or sees light only
    *Cerebral palsy (moderate and severe)
    *Cognitive impairment: BSID-III Cognitive Scale Score of <2 SDs below mean score (<70)
    *Motor impairment: BSID-III Motor Composite Scale Score of <2 SDs below mean score (<70)

    Resource utilization endpoints:
    *Number of hospital admissions, proportion of infants with any hospital admission, post-birth hospitalization discharge, by principal and secondary discharge diagnosis, type of hospital unit admitted to (e.g., NICU, Pediatric, PICU, Nursery level 3, ICU), and length of hospital stay per unit after 28 days post EDD.
    *Combined length of hospital stay in days for all hospital admissions (for infants discharged from the delivery hospitalization and for babies who were never discharged home post-delivery) after 28 days post EDD.
    *Number of ER/UC visits and proportion of infants with any ER/UC visit after 28 days post EDD.
    *Number of surgical procedures (by type and whether performed on an inpatient basis or at an outpatient/surgical center) after 28 days post EDD.
    *Number of specialty care or therapy visits and proportion of infants referred for specialty care or therapy by type of care/therapy after 28 days post EDD.
    *Parental productivity loss related to infant hospital admissions, ER/UC visits, or specialist care after 28 days post EDD.
    Desarrollo neurológico:
    - Proporción de lactantes con una puntuación de la zona negra en algún dominio del ASQ-3.
    -Proporción de lactantes con una puntuación de la zona negra en el dominio de motricidad gruesa del ASQ-3.
    -Proporción de lactantes con una puntuación de la zona negra en el dominio de motricidad fina del ASQ-3.
    -Proporción de lactantes con una puntuación de la zona negra en el dominio de comunicación del ASQ-3.
    - Proporción de lactantes con una puntuación de la zona negra en el dominio de resolución de problemas del ASQ-3.
    - Proporción de lactantes con una puntuación de la zona negra en el dominio personal-social del ASQ-3
    - Proporción de lactantes derivados a evaluación del desarrollo (mediante la BSID-III).
    -Proporción de lactantes con una puntuación < 2 DE por debajo de la media cognitiva (< 70) en la escala BSID-III.
    -Proporción de lactantes con una puntuación < 2 DE por debajo de la media de motricidad gruesa (< 70) en la escala BSID-III.
    -Proporción de lactantes con una puntuación < 2 DE por debajo de la media de motricidad fina (< 70) en la escala BSID-III.
    -Proporción de lactantes con una puntuación < 2 DE por debajo de la media de lenguaje (< 70) en la escala BSID-III.
    - Proporción de lactantes derivados a evaluación conductual complementaria según la CBCL/1.5-5 y la M-CHAT-R/F
    -Proporción de lactantes con una puntuación en la CBCL/1.5-5 que iguala o supera el percentil 97 para un subconjunto de preguntas predefinidas relacionadas con déficits de atención y de hiperactividad.
    -Proporción de lactantes en los que está indicada una nueva evaluación después de la cumplimentación de la M-CHAT-R/F
    - Proporción de lactantes derivados a evaluación neurológica para determinar un diagnóstico de parálisis cerebral.
    -Proporción de lactantes que al final del estudio presentan al menos 1 de los siguientes indicadores de deficiencia del desarrollo neurológico:
    - Deficiencia auditiva, que no se corrige con audífonos
    - Ceguera mono o bilateral, absoluta o con percepción de la luz
    - Parálisis cerebral (moderada, o grave)
    - Deficiencia cognitiva: Puntuación < 2 DE por debajo de la media (< 70) en la escala cognitiva de la BSID-III
    - Deficiencia motriz: Puntuación < 2 DE por debajo de la media (< 70) en la escala motriz compuesta de la BSID-III

    Criterios de valoración de la utilización de recursos:
    -Número de hospitalizaciones, proporción de lactantes hospitalizados,alta hospitalaria tras el nacimiento, diagnóstico principal y secundario en el alta, tipo de unidad hospitalaria (UCIN, pediátrica, UCIP, nivel 3 de enfermería, UCI, etc.) y duración de la estancia por hospitalización desde el día 28 después de la FEP.
    -Duración combinada, en días, de todas las estancias hospitalarias (en el caso de lactantes que recibieron el alta de la maternidad y de lactantes que no llegaron a recibir el alta de la maternidad) desde el día 28 después de la FEP.
    -Número de visitas de UR/CC y proporción de lactantes que visitaron el servicio de UR/CC desde el día 28 después de la FEP.
    -Número de intervenciones quirúrgicas (clasificadas por tipo y por régimen hospitalario o ambulatorio) desde el día 28 después de la FEP.
    -Número de especialistas o de tratamiento y proporción de lactantes derivados a consultas de especialistas o de tratamiento, clasificadas por tipo, desde el día 28 después de la FEP.
    -Pérdida de productividad parental relacionada con las hospitalizaciones del niño, las visitas de UR/CC o las consultas con especialistas desde el día 28 después de la FEP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days after the estimated date of delivery (EDD) and the infant's parent/legal guardian will be asked to complete a Child Health Inventory at 2, 6, 9, 12, 15, 18, 21, and 24 months of the child?s chronological age
    28 días después de la fecha estimada del parto y al progenitor/tutor legal se le pedirá que cumplimente un Inventario de Salud Infantil a los 2, 6, 9, 12, 15, 18, 21 y 24 meses de edad cronológica del niño
    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 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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Permanecerá el tratamiento de las madres en el estudio 200721. No se dará ningún fármaco a los bebés
    study treatment given to mothers in 200721 study will remain.No drug will be given to the infants
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Belgium
    France
    Germany
    Israel
    Italy
    Korea, Republic of
    Mexico
    Spain
    Sweden
    United Kingdom
    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
    Study will end when each child enrolled completes the 24 month questionnaire at either 24 months corrected age (for preterm infants) or 24 months chronological age (for term infants). Study close-out and final reporting activities will be initiated on completion of the follow-up on the last study participant.
    El estudio terminará cuando cada niño reclutado complete el cuestionario de los 24 meses, tanto si ha cumplido 24 meses de edad corregida (niños prematuros) como de edad cronológica (niños nacidos a término). Las actividades de cierre y notificación final del estudio se iniciarán cuando se complete el seguimiento del último participante del estudio.
    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 months3
    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 months3
    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: 330
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 330
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 330
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants born to mothers that participated in the Retosiban studies
    Niños nacidos de madres que han participado en estudios con Retosibán.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 330
    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)
    Not applicable
    No aplica
    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 Decision2015-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-02
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