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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-003603-61
    Sponsor's Protocol Code Number:002
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-02-23
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-003603-61
    A.3Full title of the trial
    Clinical trial on the administration of 3 doses of betamethasone (12 mg) in 18 hours apart in twin pregnancy patients with threatened preterm birth treated by Atosiban, rather than 2 doses of betamethasone (12 mg) in 24 hours apart, to decrease the risk of respiratory distress syndrome at the newborn children
    Etude clinique sur l’administration de 3 doses de betamethasone (12 mg) à 18 heures d’intervalle lors d’une menace d’accouchement prématuré dans les grossesses gémellaires traitées par Atosiban, plutôt que 2 doses de betamethasone (12 mg) à 24 heures d’intervalle, afin de diminuer le risque de syndrome de détresse respiratoire chez les nouveau-nés
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial of a new protocol of lung maturation by administration of corticoids in twin pregnancy patients with threatened preterm birth treated by Atosiban : administration of 3 doses of betamethasone (12 mg) in 18 hours apart, rather than 2 doses of betamethasone (12 mg) in 24 hours apart as used usually, to decrease the risk of respiratory distress syndrome at the newborn children
    Etude clinique d'un nouveau protocole de maturation pulmonaire par administration de corticoïdes en cas de grossesse gémellaire avec menace d’accouchement prématuré : administration de 3 doses de betamethasone (12 mg) à 18 heures d'intervalle, plutôt que 2 doses de betamethasone (12 mg) à 24 heures d'intervalle comme utilisé habituellement, afin de diminuer le risque de syndrome de détresse respiratoire chez les nouveau-nés
    A.3.2Name or abbreviated title of the trial where available
    CORTGEM 2
    CORTGEM 2
    A.4.1Sponsor's protocol code number002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    D. IMP Identification
    D.IMP: 1
    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 Celestone
    D.2.1.1.2Name of the Marketing Authorisation holderMSD
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBETAMETHASONE
    D.3.9.1CAS number 378-44-9
    D.3.9.3Other descriptive nameCELESTONE
    D.3.9.4EV Substance CodeSUB05797MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 Yes
    D.3.11.13.1Other medicinal product typeGlucocorticoids
    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
    Premature delivery in twin pregnancies
    Accouchement prématuré chez les grossesses gémellaires
    E.1.1.1Medical condition in easily understood language
    Premature delivery in twin pregnancies
    Accouchement prématuré chez les grossesses gémellaires
    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 19.1
    E.1.2Level LLT
    E.1.2Classification code 10028244
    E.1.2Term Multiple pregnancy affecting fetus or newborn
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10036564
    E.1.2Term Pregnancy multiple
    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
    Reduce the incidence of respiratory distress syndrome in twins
    Réduire l'incidence du syndrome de détresse respiratoire chez les jumeaux
    E.2.2Secondary objectives of the trial
    Reduce the other complications of prematurity in twins
    Describe the effectiveness of management of premature labor in twin pregnancy
    Réduire les autres complications de la prématurité chez les jumeaux
    Décrire l'efficacité de la prise en charge de la menace d'accouchement prématuré chez les jumeaux
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Sign inform consent
    2. Normal twin pregnancy
    3. Mother’s age between 18 and 40 years old
    4. Premature delivery risk based on cardiotocography analysis (> 6 contractions/30 minutes) with open cervix (> 1 cm) on digital examination and/or ultrasound cervical length < 25 mm
    5. Treatment with Atosiban
    1. signature du consentement éclairé
    2. grossesse gémellaire avec patiente et fœtus en bonne santé générale
    3. patientes entre 18 et 40 ans
    4. diagnostic de menace d’accouchement prématuré basé sur l’enregistrement du cardiotocogramme (6 contractions utérines ou plus durant 30 minutes), longueur du col <25 mm à l’échographie endovaginale et/ou plus d’1cm de dilatation au toucher vaginal
    5. traitement de la menace d’accouchement prématuré par de l’Atosiban
    E.4Principal exclusion criteria
    1. Medical contra-indication for tocolysis (mother or fetus)
    2. Fetal distress based on the cardiotocography and/or ultrasound
    3. Contra-indication to corticoid (infection)
    4. Other treatment with corticoid (local or general)
    5. Previous administration of corticoids for lung maturation in this pregnancy
    6. Diabetes mellitus with insulin therapy
    1. contre-indication pour la mère ou le fœtus de tocolyser
    2. souffrance fœtale, basée sur l’enregistrement du rythme cardiaque fœtal au CTG
    3. contre-indication à l’administration de corticoïdes (infection)
    4. traitement en cours par corticoïdes (voie locale ou générale)
    5. administration antérieure, lors de la grossesse en cours, de corticoïdes pour prévenir le syndrome de détresse respiratoire
    6. diabète maternel insulinodépendant
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of respiratory distress syndrom in the two groups
    Grade of respiratory distress syndrom in the two groups
    Proportion de syndrome de détresse respiratoire dans les deux groupes
    Grade du syndrome de détresse respiratoire dans les deux groupes
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of these criteria at birth and during the stay in neonatalogy
    Evaluation de ces critères à la naissance et durant le séjour en néonatologie
    E.5.2Secondary end point(s)
    Gestational age at delivery
    Incidence of other neonatal complications
    Need for neonatal surfactant therapy in both groups
    Need for ventilator support
    Incidence of long-term respiratory complications
    Âge gestationnel au moment de l’accouchement
    Incidence d’autres complications néonatales
    Nécessité d’un traitement par surfactant
    Nécessité d’une ventilation mécanique ou d’un masque C-PAP
    Incidence des complications respiratoires à long terme
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of the first four criteria at birth and during the stay in neonatology
    The incidence of the long-term respiratory complications will be estimated at 12 and 22 months of life
    Evaluation des quatre premiers critères à la naissance et durant le séjour en néonatologie
    L'incidence des complications respiratoires à long terme sera évaluée à 12 et 22 mois de vie
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Administration de doses différentes
    Other dosis administration
    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 concerned2
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 50
    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 No
    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 state50
    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)
    No difference with the normal treatment
    Pas de différence avec le traitement habituel
    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 Decision2017-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-01-01
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