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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2015-001721-16
    Sponsor's Protocol Code Number:2014_09
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-27
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-001721-16
    A.3Full title of the trial
    SUFENTANIL maternal and foetal pharmacokinetic evaluation after intra–amniotic injection
    EVALUATION DE LA PHARMACOCINETIQUE FŒTALE ET MATERNELLE DU SUFENTANIL APRES INJECTION INTRA-AMNIOTIQUE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SUFENTANIL intra–amniotic injection
    INJECTION INTRA-AMNIOTIQUE DE SUFENTANIL
    A.3.2Name or abbreviated title of the trial where available
    2IAS
    A.4.1Sponsor's protocol code number2014_09
    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 SponsorCentre Hospitalier Régional et Universitaire de Lille
    B.1.3.4CountryFrance
    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 supportCentre Hospitalier Régional et Universitaire de Lille
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Régional et Universitaire de Lille
    B.5.2Functional name of contact pointClinical Research Associate
    B.5.3 Address:
    B.5.3.1Street AddressDélégation à la Recherche Clinique et à l’Innovation - 6 rue du Professeur Laguesse
    B.5.3.2Town/ cityLILLE
    B.5.3.3Post code59037
    B.5.3.4CountryFrance
    B.5.4Telephone number33320444145
    B.5.5Fax number33320445711
    B.5.6E-mailedouard.millois@chru-lille.fr
    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 SUFENTANIL
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameSUFENTANIL
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraamniotic 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
    il n’existe pas actuellement de consensus sur les protocoles d’analgésie fœtale lors des gestes invasifs in-utero, encore moins lors de pathologies malformatives potentiellement douloureuses. En effet, l’analgésie fœtale se heurte aux problèmes suivants : 1) comment évaluer la douleur chez le fœtus et comment évaluer l’efficacité d’un traitement analgésique ? ; 2) quelle analgésie et quelle voie d’administration utiliser en considérant la balance bénéfice/risque pour l’entité « mère-fœtus » ?
    E.1.1.1Medical condition in easily understood language
    Foetal analgesia during the invasive gestures in-utero
    Analgésie fœtale lors des gestes invasifs in-utero
    E.1.1.2Therapeutic area Body processes [G] - Chemical Phenomena [G02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLGT
    E.1.2Classification code 10053098
    E.1.2Term Foetal and neonatal investigations
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We shall try to estimate the fotal plasma absorption of the SUFENTANIL after an intra-amniotic injection during the procedures of medical interruption of pregnancy with fœticide. We wish to know if this method of administration allows to obtain therapeutic fetal concentrations of morphine.
    Nous chercherons à évaluer l’absorption plasmatique fœtale du SUFENTANIL après une injection intra-amniotique lors des procédures d’interruption médicale de grossesse avec fœticide. Nous souhaitons savoir si ce mode d’administration permet d’obtenir des concentrations fœtales thérapeutiques en morphinique.
    E.2.2Secondary objectives of the trial
    Know if the SUFENTANIL administered by intra-amniotic route allows to obtain therapeutic serum levels without maternal and fetal adverse event
    Savoir si le SUFENTANIL administré par voie intra-amniotique permet d’obtenir des taux sériques thérapeutiques sans effet indésirable maternel et fetal
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women aged 18 and over
    Member of French social security scheme
    Single pregnancy
    Hospitalized subject for medical termination of pregnancy
    Gestational age equal to or greater than 24 weeks of amenorrhea
    Inform consent form signature
    Patiente âgée de 18 ans et plus
    Patiente affiliée à un régime de sécurité sociale
    Grossesse unique
    Patiente hospitalisée pour interruption médicale de grossesse avec arrêt de vie in utero
    Age gestationnel supérieur ou égal à 24 semaines d’aménorrhée (âge limite de réalisation d’un arrêt de vie in utero)
    Accord après information écrite et consentement éclairé de la patiente
    E.4Principal exclusion criteria
    Women under age 18 (minor)
    Under tutorship or guardianship
    Selective medical terminiation during multiple pregnancy
    Foetal deformation which can interfere on the foetal absorption of SUFENTANIL (gastrochisis, omphalocele...), fetal swallowing disorder (thyroid goiter, cervical mass ...)
    Emergency procedures
    Allergic maternal history known about the SUFENTANIL or morphine
    Contraindications in the anesthesia epidural which can give appeal to the use of morphines substances for medical termination of pregnancy
    Medical necessity of a maternal treatment considered by the anaesthetist as being able to interfere with the injection of SUFENTANIL
    Addicted to morphine
    Morphine long-term treatment
    Maternal cardiac or respiratory pathology against indicating a treatment by SUFENTANIL
    Refusal of the patient to participate in the study after information



    Patiente mineure
    Patiente sous tutelle ou curatelle
    Interruption sélective lors de grossesses multiples
    Malformation fœtale pouvant interférer sur l’absorption fœtale de SUFENTANIL (laparoschisis, omphalocèle…), trouble de la déglutition fœtale (goître thyroïdien, masse cervicale…)
    Procédure en urgence
    Antécédent maternel allergique connu au SUFENTANIL ou à un morphinique
    Contre-indications à l’anesthésie péridurale pouvant donner recours à l’utilisation de substances morphiniques pour la prise en charge de l’interruption médicale de grossesse (IMG)
    Nécessité médicale d’un traitement maternel considéré par l’anesthésiste comme pouvant interférer avec l’injection de SUFENTANIL
    Toxicomanie aux morphiniques
    Traitement au long cours par morphinique
    Pathologie cardiaque ou respiratoire maternelle contre indiquant un traitement par SUFENTANIL
    Refus de la patiente de participer à l’étude après information
    E.5 End points
    E.5.1Primary end point(s)
    Morphine derivatives fetal plasma concentrations
    Concentrations plasmatique fœtale en dérivés morphiniques
    E.5.1.1Timepoint(s) of evaluation of this end point
    Sampling of blood for the SUFENTANIL fetal plasma level 30 minutes after the injection (Intraumbilical)
    Prélèvement sanguin pour le dosage plasmatique fœtal du SUFENTANIL à 30 minutes de l’injection (intra-cordale)
    E.5.2Secondary end point(s)
    Morphine derivatives maternal plasma concentrations
    Morphine derivatives amniotic fluid concentrations
    Maternal and fetal Adverse events / serious adverses events
    Les concentrations plasmatiques maternelles en dérivés morphiniques permettront de s’assurer que le SUFENTANIL injecté par voie intra-amniotique est faiblement absorbé.

    Les concentrations du liquide amniotique en dérivés morphiniques seront également évaluées.

    Nous vérifierons l’absence d’effets indésirables maternels et foetaux
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Sampling of blood for the SUFENTANIL maternal plasma level (catheter):
    • 30 minutes after the injection
    • 60 minutes after the injection
    • 120 minutes after the injection
    • 24 hours after the injection

    - Sampling of amniotic fluid for the SUFENTANIL level:
    • When the needle is removed

    - Maternal and fetal Adverse events / serious adverses events data captures
    - Prélèvements sanguins pour le dosage plasmatique maternel du SUFENTANIL par cathéter :
    • A 30 min de l’injection
    • A 60 min de l’injection
    • A 120 min de l’injection
    • A 24 h de l’injection

    - Prélèvement de liquide amniotique pour le dosage du SUFENTANIL :
    • Au retrait de l’aiguille

    - Surveillance de Evènements indésirables et Evènements indésirables graves :
    •l’absence d’effets indésirables maternels avec surveillance après l’injection de la pression artérielle, de la fréquence cardiaque, de la fréquence respiratoire et de l’état de conscience. Cette surveillance sera réalisée pendant 24h dont 2h au bloc obstétrical
    •l’absence d’effets indésirables fœtaux avec la surveillance du rythme cardiaque fœtal de l’injection de SUFENTANIL au fœticide à l’aide d’un cardiotocographe
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 No
    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 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
    Last Patient Last Visit
    Dernière visite de la dernière patiente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned 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: 35
    F.1.1.1In Utero Yes
    F.1.1.1.1Number of subjects for this age range: 35
    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: 35
    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 state35
    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 patient will be watched during 24 hours among which 2 hours in the obstetric block after the intra-amniotic injection. An anaesthetist and a nurse anaesthetist will be present in the room during all the procedure. All the emergency material is present in the obstetric block. In case of bradypnea, apnea or appearance of a slumber, a reversion by NARCAN can be decided by the anaesthetist.
    La patiente sera surveillée pendant 24h dont 2 heures au bloc obstétrical après l’injection intra amniotique. Un anesthésiste et un infirmier anesthésiste seront présents dans la salle pendant toute la procédure. Tout le matériel d’urgence est présent dans le bloc obstétrical. Une garde sur place de 24h permet d’assurer la sécurité de la patiente. En cas de bradypnée ou d’apnée ou d’apparition d’une somnolence, une réversion par NARCAN® pourra être décidée par l’anesthésiste.
    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 Decision2015-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
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