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    Summary
    EudraCT Number:2014-001826-13
    Sponsor's Protocol Code Number:200721
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-05-12
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-001826-13
    A.3Full title of the trial
    Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor
    Studio di fase III, multicentrico, randomizzato, in doppio cieco, per confrontare l’efficacia e la sicurezza della terapia con Retosiban versus Atosiban nelle donne con travaglio pretermine spontaneo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to compare Retosiban with Atosiban and show that retosiban is more effective in stopping spontaneous preterm labor and prolonges labor
    Lo scopo di questo studio è confrontare Retosiban con Atosiban e dimostrare che Retosiban è più efficace dell'interruzione dl travaglio pretermine spontaneo e nel prolungamento del travaglio
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number200721
    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 RESEARCH AND DEVELOPMENT
    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 supportGlaxoSmithKline
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    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 number02089903879
    B.5.5Fax number02089903511
    B.5.6E-mailrobert.c.stocken@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.2.5The 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 codeGSK221149
    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 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 infusion
    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 labor
    Travaglio pretermine
    E.1.1.1Medical condition in easily understood language
    Restosiban stops preterm labor and prolongs pregnancy
    Retosiban blocca il travaglio pretermine e prolunga la gravidanza
    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 10073024
    E.1.2Term Preterm premature rupture of membranes
    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
    To demonstrate the superiority of retosiban to prolong pregnancy compared with atosiban
    L'obiettivo primario è dimostrare la superiorità di retosiban nel prolungare la gravidanza rispetto ad atosiban.
    E.2.2Secondary objectives of the trial
    To describe the outcomes of newborns during the neonatal period (through 28 days post estimated date of delivery [EDD]) for retosiban compared with atosiban
    To describe the maternal, fetal, and neonatal safety profile during and after IV retosiban treatment compared with atosiban treatment
    To determine the effect of retosiban treatment compared with atosiban on health care resource use and patient-reported outcomes associated with the maternal and neonatal hospitalization
    To obtain further data on the pharmacokinetics of retosiban in pregnant women, including the effect of covariates such as age, weight, race/ethnicity, and GA on retosiban clearance and volume of distribution
    Descrivere il profilo di sicurezza materno, fetale e neonatale durante e dopo il trattamento con retosiban per via endovenosa (IV) rispetto al trattamento con atosiban;
    -Determinare l'effetto del trattamento con retosiban rispetto ad atosiban per quanto riguarda l'uso di risorse per l'assistenza sanitaria e gli esiti riportati dal paziente in associazione con la degenza ospedaliera materna e neonatale;
    -Ottenere ulteriori informazioni sulla farmacocinetica di retosiban nelle donne in gravidanza, incluso l'effetto delle covariate come l'età, il peso, la razza/etnia e la GA sulla clearance di retosiban e sul volume di distribuzione.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed and dated written informed consent is required prior to a subject’s participation in the study and the performance of any protocol specific procedures. Adolescents aged 12 to 17 years must provide written agreement to participate in the study in accordance with applicable regulatory and country or state requirements. Subjects will also be asked to sign a release for medical records at the time of consenting to allow access to both the maternal and neonatal records including information about delivery and infant care as well as information collected prior to the consent having been signed
    Note: Prescreening alone does not necessarily require consent as this activity may be accomplished in the absence of study specific procedures or assessments. In many cases, standard care and standard medical triage will provide sufficient information or evidence as to whether or not the subject is eligible for the study
    2.Females aged 12 to 45 years, with an uncomplicated, singleton pregnancy and intact membranes in preterm labor (Note: This protocol includes pregnant adolescents, aged 12 to 17 years, as appropriate, based on national or local regulations.)
    3.Gestational age between 240/7 and 336/7 weeks as determined by (1) known fertilization date, either in vitro fertilization or intrauterine insemination, (2) last menstrual period confirmed by the earliest ultrasound prior to 240/7 weeks’ gestation, or (3) the earliest ultrasound alone prior to 240/7 weeks’ gestation, whichever is the most accurate method available for each subject. In situations where prenatal ultrasound records are not available at the time the subject presents, the investigator will make every effort to obtain these records (either via computer records, directly from the subject’s primary care obstetrician, or via telephone). However, in cases in which these records are not readily available (e.g., off hours, holiday), it is within the investigator’s discretion to use GA based on a verbal history from the subject with the intent of getting confirmation from the medical records as soon as possible
    4.Subjects must be diagnosed with preterm labor according to both of the following criteria:
    a.Regular uterine contractions at a rate of ≥4 contractions of at least 30 seconds duration during a 30-minute interval confirmed by tocodynamometry
    AND at least 1 of the following:
    b.Cervical dilation ≥2 cm and ≤4 cm by digital cervical examination OR
    c.If <2 cm dilation by digital cervical examination, a cervical change consisting of an increase of at least 25% effacement or 1 cm dilation
    5.Treatment naïve subjects and subjects not adequately responding to tocolytics other than atosiban (e.g., transfers from other care units) during their current episode of preterm labor may be eligible for the study. Historical failure of a tocolytic treatment in a previous episode of preterm labor is not a required inclusion criterion. Tocolytic failure is defined by progressive cervical changes or continuing uterine contractions
    I soggetti idonei per l'arruolamento allo studio devono soddisfare tutti i seguenti criteri:
    1. Il consenso informato scritto, datato e firmato è necessario prima della partecipazione allo studio da parte del soggetto e prima che venga eseguita qualsiasi procedura specifica indicata nel protocollo.. Alle pazienti verrà inoltre chiesto di firmare un modulo per il rilascio di documentazione medica nel momento in cui firmano il consenso, al fine di autorizzare l'accesso alle cartelle cliniche materne e del neonato, incluse le informazioni relative al parto e alla cura del bambino nonché alle informazioni raccolte prima della firma del consenso
    Nota: il pre-screening da solo non richiede necessariamente il consenso, poiché questa attività può essere completata in assenza di procedure o valutazioni specifiche dello studio. In molti casi, le cure standard e il triage medico standard forniscono le informazioni o le prove necessarie per determinare se il soggetto è idoneo per lo studio oppure no
    2. Donne di età compresa tra i 18 e i 45 anni, con gravidanza singola non complicata e membrane intatte in travaglio pretermine
    3. Età gestazionale dalla 240/7 alla 336/7 settimana determinata da (1) data di fecondazione nota, fecondazione in vitro o inseminazione intrauterina, (2) ultimo ciclo mestruale confermato dalla prima ecografia eseguita prima della settimana 240/7 di gestazione, o (3) la sola prima ecografia eseguita prima della settimana 240/7 di gestazione, a seconda di quale sia il metodo di valutazione più accurato disponibile per ciascun soggetto. Nelle situazioni in cui le cartelle dell'ecografia prenatale non sono disponibili nel momento in cui la paziente si presenta, lo sperimentatore profonderà tutti gli sforzi possibili per ottenere queste cartelle (attraverso i dati in formato elettronico ottenuti direttamente dall'ostetrico della paziente o per via telefonica). Tuttavia, nei casi in cui le cartelle non sono subito disponibili (es. ore di pausa, vacanze), è a discrezione dello sperimentatore l'uso della GA basata sulla storia verbale della paziente con l'intento di ricevere conferma dalle cartelle cliniche il prima possibile
    4. Alle pazienti deve essere diagnosticato un travaglio pretermine secondo entrambi i criteri seguenti:
    a. Contrazioni uterine regolari con una frequenza di ≥4 contrazioni della durata di almeno 30 secondi durante un intervallo di 30 minuti confermato da tocodinamometro.
    E almeno uno dei seguenti:
    b. Dilatazione cervicale ≥2 cm e ≤4 cm secondo l'esame digitale della cervice OPPURE
    c. Se la dilatazione è <2 cm secondo l'esame digitale della cervice, un cambiamento della cervice consistente in un aumento della maturazione almeno del 25% o 1 cm di dilatazione
    5. Le pazienti naive al trattamento e le pazienti che non rispondono adeguatamente ai tocolitici diversi da atosiban (es., trasferimenti da altri reparti) durante il loro attuale episodio di travaglio pretermine possono essere idonee per lo studio. Una storia di fallimento del trattamento tocolitico in un precedente episodio di travaglio pretermine non è un criterio di inclusione richiesto. Il fallimento del trattamento tocolotico è definito da cambiamenti progressivi della cervice o contrazioni uterine continue.
    E.4Principal exclusion criteria
    1.Fever with a temperature greater than 100.4°F (38°C) for more than 1 hour or ≥101°F (38.3°C) in the 24 hours prior to the start of study treatment
    2.Women with maternal-fetal conditions that potentially necessitate the need for delivery, such as pre-eclampsia or fetal compromise
    3.A fetus with any diagnosis, condition, treatment, or other factor that in the opinion of the investigator has the potential to affect or confound assessments of efficacy or safety (e.g., nonreassuring fetal status, intrauterine growth restriction, major congenital anomaly)
    4.Preterm premature rupture of membranes
    5.Women with any confirmed or suspected contraindication to prolongation of pregnancy, such as placental abruption, chorioamnionitis, or placenta previa
    6.Evidence of polyhydramnios (amniotic fluid index [AFI] >25 cm) or oligohydramnios (AFI <5 cm)
    7.Women with co-morbid medical or obstetric conditions that in the opinion of the investigator have the potential to complicate the pregnancy course and outcomes, such as uncontrolled hypertension, uncontrolled diabetes (if known, history of glycosylated hemoglobin >8% at any time during pregnancy), or compromise the safety of the subject, such as underlying cardiovascular disorder (specifically ischemic cardiac disease, congenital heart disease, pulmonary hypertension, valvular heart disease, arrhythmias, and cardiomyopathy)
    8.Women with a history of substance abuse or urine drug screen findings suggestive of substance abuse that may either be implicated as the cause of preterm labor (e.g., abuse of cocaine or methamphetamines) or have the potential to complicate the pregnancy outcome (e.g., alcohol abuse or opioid addiction)
    9.Women with any diagnosis, condition, treatment, or other factor that in the opinion of the investigator has the potential to affect or confound assessments of efficacy or safety
    10.Women with documented active hepatitis B or hepatitis C viral infection, unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones)
    11.History of sensitivity to the IPs or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK/PPD medical monitor,
    1. Febbre con una temperatura superiore a 38 °C per più di un'ora o 38,3 °C nelle 24 ore precedenti l'inizio del trattamento dello studio
    2. Donne con condizioni materne-fetali che implichino potenzialmente la necessità di partorire, come preeclampsia o compromissione fetale
    3. Un feto con qualunque diagnosi, condizione, trattamento o altro fattore che secondo l'opinione dello sperimentatore può potenzialmente compromettere o confondere l'efficacia o la sicurezza (es. stato fetale non rassicurante, restrizione della crescita intrauterina, anomalie congenite rilevanti)
    4. Rottura prematura pretermine delle membrane
    5. Donne con sospetta o confermata controindicazione al prolungamento della gravidanza, come nel caso di distacco placentare, corioamniosite o placenta previa
    6. Evidenza di polidramniosi (indice liquido amniotico [AFI] >25 cm) o oligoidramniosi (AFI <5 cm)
    7. Donne con condizione mediche o ostetriche di co-morbilità che secondo l'opinione dello sperimentatore possono potenzialmente complicare il corso e l'esito della gravidanza, come ipertensione non controllata, diabete non controllato (se nota, anamnesi di emoglobina glicosilata >8% in qualsiasi momento durante la gravidanza), o compromettere la sicurezza della paziente, come nel caso di malattia cardiovascolare preesistente (nello specifico, malattia cardiaca ischemica, malattia cardiaca congenita, ipertensione polmonare, malattia valvolare cardiaca, aritmie, e cardiomiopatia)
    8. Donne con anamnesi di abuso di sostanze o esame tossicologico delle urine con risultati che suggeriscono un abuso di sostanze che può essere implicato come la causa del travaglio pretermine (es. abuso di cocaina o anfetamine) o può potenzialmente complicare l'esito della gravidanza (es. abuso di alcol o dipendenza da oppioidi)
    9. Donne con qualunque diagnosi, condizione, trattamento o altro fattore che secondo l'opinione dello sperimentatore può potenzialmente compromettere o confondere le valutazioni di efficacia o di sicurezza
    10. Donne con epatite B documentata o infezione virale da epatite C, malattia epatica instabile (come definita dalla presenza di ascite, encefalopatia, coagulopatia, ipoalbuminemia, varici esofagee o gastriche o ittero persistente), cirrosi, anomalie biliari (fatta eccezione per sindrome di Gilbert o calcoli biliari asintomatici)
    11. Anamnesi di sensibilità all'IP o ai suoi componenti o anamnesi di allergia a farmaci o di altra allergia che, a giudizio dello sperimentatore o del medical monitor GSK/PPD, costituisca una controindicazione alla partecipazione.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is time to delivery from the start of IP administration until delivery,
    L'endpoint primario di efficacia è il tempo al parto dall'inizio della somministrazione dell'IP fino al parto, sulla base di una revisione delle cartelle.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours after IP infusion, then every week till delivery.
    48 ore dopo l'infusione dell'IMP, successivamente ogni settimana dopo il parto.
    E.5.2Secondary end point(s)
    The following are the key secondary efficacy endpoints:
    Proportion of births prior to 370/7 weeks’ gestation
    Proportion of births at term (370/7 to 416/7 weeks’ gestation)
    Length of neonatal hospital stay
    Proportion of neonates with any diagnosis from the neonatal morbidity and mortality composite determined up to 28 days after EDD (of 400/7 weeks) (details for each composite are provided in Section 6.2.2)
    Fetal or neonatal death
    Respiratory distress syndrome (RDS)
    Bronchopulmonary dysplasia
    Necrotizing enterocolitis or isolated perforation
    Sepsis
    Meningitis
    Retinopathy of prematurity
    Intraventricular hemorrhage (IVH)
    White matter injury,
    Cerebellar hemorrhage

    The following are other secondary efficacy endpoints:
    Proportion of neonates with any of the composite neonatal morbidity and mortality excluding RDS
    Proportion of neonates with each individual component of the composite neonatal morbidity and mortality endpoints
    Neonatal admission to a specialized care unit and length of stay
    Newborn hospital readmission and length of stay
    Ambulatory surgery
    Proportion of births prior to 280/7 weeks’ gestation
    Proportion of births prior to 320/7 weeks’ gestation
    Proportion of births ≤7 days
    Proportion of births ≤48 hours
    Proportion of births ≤24 hours

    The following are the safety endpoints (maternal, fetal, and neonatal, as appropriate):
    Incidence of reported AEs and serious AEs
    Significant changes in vital signs and clinical laboratory tests
    Incidence of treatment-limiting toxicities including both clinical and laboratory etiology causing subject to discontinue study treatment
    Edinburgh Postnatal Depression Scale
    Follow-up amniotic fluid index determined by abdominal ultrasound
    Fetal acidosis
    Neonatal Apgar scores (at 1 and 5 minutes after birth), growth parameters (weight, length, and head circumference) at birth and at discharge, and documentation of any complications
    AEs of special interest
    Maternal
    Death
    Chorioamnionitis and its complications
    Placental abruption
    Postpartum hemorrhage and/or retained placenta
    Pulmonary edema
    Fetal
    Intrauterine fetal demise
    Category II or III fetal heart rate tracing (defined according to American College of Obstetricians and Gynecologists Practice Bulletin 106 [ACOG, 2009])
    Fetal inflammatory response syndrome
    Neonatal
    Neonatal death
    Asphyxia
    Infections (early onset neonatal sepsis, septic shock, pneumonia, meningitis)
    RDS
    Hypotension
    Intraventricular hemorrhage/periventricular leukomalacia
    Bronchopulmonary dysplasia
    Neonatal acidosis
    Hyperbilirubinemia
    Neonatal enterocolitis
    Hypoxic ischemic encephalopathy
    • Proporzione di nascite prima delle 370/7 settimane di gestazione • Proporzione di nascite al termine (da 370/7 a 416/7 settimane di gestazione) • Durata della degenza ospedaliera neonatale • Proporzione di neonati con eventuali diagnosi dal composito di morbilità e mortalità neonatale determinata fino a 28 giorni dopo EDD (delle 400/7 settimane) (i dettagli per ogni composito sono forniti nella Sezione 6.2.2) • Decesso fetale o neonatale • Sindrome da distress respiratorio (RDS) • Displasia broncopolmonare • Enterocolite necrotizzante o perforazione isolata • Sepsi • Meningite • Retinopatia del prematuro • Emorragia intraventricolare (IVH) • Lesione della sostanza bianca • Emorragia cerebellare .
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 hours after IP infusion, then every week till delivery.
    48 ore dopo l'infusione dell'IMP, successivamente ogni settimana dopo il parto
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Double dummy
    double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Atosiban
    Atosiban
    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
    LVLS
    LVLS
    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 months0
    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 months0
    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: 324
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    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)
    The investigator is responsible for ensuring that consideration has been given to the poststudy care of the subject’s medical condition whether or not GSK is providing specific poststudy treatment.
    Poststudy IP is not provided as part of this protocol.
    Lo sperimentatore è responsabile di assicurare il trattamento post sperimentazione basati sulle condizioni mediche dei soggetti, GSK non prevede trattamenti specifici post trattamento di studio. Dopo la partecipazione allo studio l'IMP non sarà fornito.
    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 Opinion2015-03-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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