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    Summary
    EudraCT Number:2014-000499-24
    Sponsor's Protocol Code Number:200722
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-05-14
    Trial 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 ConcernedItaly - Italian Medicines Agency
    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 Partecipating in Retosiban Treatment Studies
    Studio di follow-up per valutare la sicurezza e gli esiti a lungo termine nei bambini nati da madri partecipanti agli studi di trattamento con Retosiban
    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
    Lo scopo di questo studio è monitorare la sicurezza del trattamento utilizzato per il travaglio pretermine in altri studi per raccogliere informazioni sulla salute e lo sviluppo dei bambini a seguito della partecipazione della madre nella sperimentazione con retosiban per il travaglio pretermine durante la loro gravidanza.
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number200722
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    A.5.4Other Identifiers
    Name:NANumber:NA
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/20/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGLAXOSMITHKLINE S.P.A.
    B.1.3.4CountryItaly
    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 supportAzienda Farmaceutica: Glaxosmithkline 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 codeUB111BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00442089903879
    B.5.5Fax number00442089903511
    B.5.6E-mailrobert.c.stoken@gsk.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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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.3.9.3Other descriptive nameGSK 221149A
    D.3.9.4EV Substance CodeSUB29510
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 AuthorisationGermany
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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: 3
    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 AuthorisationGermany
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Travaglio pretermin ed incremento della sicurezza neonatale
    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 etosiban study for preterm labor during mother's pregnancy
    travaglio pretermine e salute e sviluppo dei bambini dopo la partecipazione delle madri negli studi con retosiban per il travaglio pretemrine durante la gravidanza delle madri
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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 studies
    L'obiettivo dello studio è valutare la sicurezza e gli esiti nei bambini che sono stati esposti a Retosiban o farmaco comparatore nell'ambito di studi di trattamento di fase III su SPTL
    E.2.2Secondary objectives of the trial
    -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.
    The study objective is to assess the safety and outcomes in infants who were exposed to retosiban or comparator in the Phase III treatment studies
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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.
    I bambini idonei per l'arruolamento allo studio devono soddisfare tutti i seguenti criteri:
    1.La madre è randomizzata e ha ricevuto una dose (Retosiban o farmaco comparatore) in 1 degli studi clinici di fase III su SPTL con Retosiban.
    2.Il bambino è vivo a 28 giorni post EDD.
    3.È stato ottenuto il consenso informato scritto dal/i genitore/i o tutore/i legale/i del bambino
    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.
    Poiché questo studio si concentra sulla sicurezza e gli esiti nel bambino, tutti i bambini che soddisfano i criteri di inclusione saranno idonei all'arruolamento nello studio. Non vi sono criteri di esclusione formali per la partecipazione.
    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.
    Endpoint di morbilità e mortalità: -Proporzione di bambini a cui sono state recentemente diagnosticate (dopo 28 giorni post EDD) condizioni mediche croniche, segnalate secondo il tipo di condizione e inclusive delle seguenti: •Condizioni respiratorie •Condizioni neurologiche •Condizioni sensoriali •Condizioni gastrointestinali •Condizioni cardiovascolari •Condizioni renali •Parametri di crescita •Proporzione di bambini a cui sono state recentemente diagnosticate (dopo 28 giorni post EDD) anomalie congenite •Proporzione di decessi di neonati e bambini dopo 28 giorni post EDD e fino alla fine dello studio
    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 raccolata dei dati di morbilità avverrà al 28esimo giorno dopo la presunta data del parto (EDD) ed ai genitori/legali rappresentanti sarà chiesto di compilare il Child Health Inventory ai mesi 2,6,9,12,15,18,21 e 24 che corrispondono ai mesi anagrafici del bambino
    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)
    Endpoint di sviluppo neurologico: -Endpoint di sviluppo neurologico valutati alle età di 9, 18, e 24 mesi, corrette per i prematuri: •Proporzione di bambini con un punteggio ASQ-3 nella zona nera in ogni ambito •Proporzione di bambini con un punteggio ASQ-3 nella zona nera per le abilità grosso-motorie •Proporzione di bambini con un punteggio ASQ-3 nella zona nera per le abilità fino-motorie •Proporzione di bambini con un punteggio ASQ-3 nella zona nera per la comunicazione •Proporzione di bambini con un punteggio ASQ-3 nella zona nera per problem solving •Proporzione di bambini con un punteggio ASQ-3 nella zona nera per le capacità personali-sociali •Proporzione di bambini inviati a uno specialista per la valutazione dello sviluppo (con l'uso di BSID III) •Proporzione di bambini con un punteggio BSID-III <2 SDs sotto il punteggio medio per la compromissione cognitiva (<70) •Proporzione di bambini con un punteggio BSID-III <2 SDs sotto il punteggio medio per le abilità grosso-motorie (<70) •Proporzione di bambini con un punteggio BSID-III <2 SDs sotto il punteggio medio per le abilità fino-motorie (<70) •Proporzione di bambini con un punteggio BSID-III <2 SDs sotto il punteggio medio per il linguaggio (<70) •Proporzione di bambini inviati a uno specialista per una valutazione comportamentale aggiuntiva con l'uso di CBCL/1.5-5 e M-CHAT-R/F •Proporzione di bambini con un punteggio CBCL/1.5–5 di o superiore al 97° percentile per un sottogruppo di domande prestabilite che fanno riferimento a problemi di attenzione e iperattività •Proporzione di bambini indicati come bisognosi di un'ulteriore valutazione dopo il completamento della M CHAT R/F •Proporzione di bambini inviati da uno specialista per una valutazione neurologica al fine di determinare una diagnosi di paralisi cerebrale •Proporzione di bambini con almeno 1 dei seguenti indicatori della compromissione dello sviluppo neurologico alla fine dello studio: •Udito compromesso, non corretto nonostante gli auricolari •Cecità in 1 o entrambi gli occhi, o visione solo delle luci •Paralisi cerebrale (moderata e grave) •Compromissione cognitiva: Punteggio sulla Scala Cognitiva BSID-III di <2 SDs sotto il punteggio minimo (<70) •Compromissione motoria: Punteggio sulla Scala Cognitiva BSID-III di <2 SDs sotto il punteggio minimo (<70)
    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 giorni dopo la data stimata del parto (EDD) ed ai genitori/legali rappresentanti del bambino sarà chiesto di completare il Child Health Inventory ai mesi 2,6,9,12,15,18, 21 e 24 che corrispondono ai mesi anagrafici dei bambini.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    I bambini saranno stratificati in base al trattamento assegnato alle madri.
    Infants will be assigned to the same treatment group to which mothers were assigned
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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 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
    Israel
    Korea, Republic of
    Mexico
    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
    Lo studio terminerà quando ogni bambino sarà arruolato e sarà completato il questionario del 24esimo mese di vita (per i bambini nati pretermine) o 24 mesi di età anagrafica (per i bambini nati a termine). Lo studio terminerà e le attività di elaborazione dati inizieranno all'atto del completamento del follow-up dell'ultimo partecipanti allo studio.
    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 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 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
    bambini nati da madri che hanno partecipato a studi con retosiban
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    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)
    NA
    NA
    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 Decision2015-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-14
    P. End of Trial
    P.End of Trial StatusOngoing
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