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    Summary
    EudraCT Number:2013-002561-19
    Sponsor's Protocol Code Number:1
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-01-23
    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 ConcernedAustria - BASG
    A.2EudraCT number2013-002561-19
    A.3Full title of the trial
    A prospective, double blind, randomised, placebo controlled trial to evaluate the effect of a long term tokolysis with atosiban on the pregnancy outcome. A pilot study.
    Eine prospektive, doppelblind randomisierte, plazebokontrollierte Studie zur Evaluierung der Langzeittokolyse mit Atosiban in Bezug auf das Schwangerschaftsoutcome. Eine Pilotstudie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does a long term tokolysis with atosiban provide any benefit for the pregnancy outcome, compared to the standard short term tokolysis?
    A.3.2Name or abbreviated title of the trial where available
    Long term tokolysis with atosiban
    A.4.1Sponsor's protocol code number1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedizinische Universität Wien, Univ.Klinik f.Frauenheilkunde,Abt. f.Geburtshilfe und Feto-maternale Medizin
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedizinische Universität Wien, Abteilung für Geburtshilfe und Feto-maternale Medizin
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Wien, Abteilung für Geburtshilfe und Feto-maternale Medizin
    B.5.2Functional name of contact pointStudiensekreteriat Geburtshilfe
    B.5.3 Address:
    B.5.3.1Street AddressWaehringer Guertel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number00431404002881
    B.5.5Fax number00431404002323
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name 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 Concentrate for 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 INNATOSIBAN
    D.3.9.1CAS number 90779-69-4
    D.3.9.3Other descriptive nameAtosiban
    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 number6,75
    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 placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Premature uterine contractions
    premature labor
    E.1.1.1Medical condition in easily understood language
    patients suffering from preterm labor or shortening of the cervix
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10068718
    E.1.2Term Premature uterine contractions
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10036599
    E.1.2Term Premature labor
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of long term tocolysis with atosiban on the pregency outcome. (Gestational age at delivery)
    E.2.2Secondary objectives of the trial
    Prolongation of pregnancy, time intervall til recurrant preterm labor, cervical length/shortening of the cervix, drop out rate
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    intact singleton pregnancy between 23+0 and 28+0 weeks gestation

    intact membranes

    cervical length ≤ 15mm

    immediate previous completion of standard tocolysis with atosiban for 48 hours

    Able to communicate well with the investigator, to understand and comply with the requirements of the study

    Signed the written informed consent

    women over 18 years
    E.4Principal exclusion criteria
    rupture of membranes
    Amnion infection syndrome, fever (>38°C)
    vaginal bleeding with intensity of menstruation or above
    placenta praevia
    polyhydramnion
    congenital malformations, deformations and chromosomal abnormalities
    preexistant Diabetes Typ I or II
    multiple pregnancies
    Prolaps of membranes till the external cervical os.
    E.5 End points
    E.5.1Primary end point(s)
    Does a long term tocolysis with atosiban lead to a prolongation of
    pregancy?

    1.)Time ( in days) until recurrence of preterm labor with effect on the cervical length during the study period.


    If 1 is significant:
    2.) Time untill delivery during study period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    recurrence of labor
    delivery
    E.5.2Secondary end point(s)
    gestational age at birth

    Time period (days) after long term tocolysis ( after the end of the study period) until birth

    time period (days) after routine tocolysis (48hrs) until birth.

    Time period (days) after the study period until recurrence of preterm labor with effect on the cervical length.

    need for another tocolysis cycle after the study period until SSW 33+6.

    Delivery before gestational age 28+0, 30+0, 33+6

    Perinatal Mortality

    Perinatal Morbidity- Perinatal Morbidity composite index

    Side effects of the therapy (study period)
    E.5.2.1Timepoint(s) of evaluation of this end point
    recurrence of preterm labor and delivery
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of the trial is reached as soon as the last subject had delivered the baby/ babies.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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: 60
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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)
    none
    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 Decision2014-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-11-30
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