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    Summary
    EudraCT Number:2019-003290-26
    Sponsor's Protocol Code Number:APHP190210
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2019-09-13
    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 number2019-003290-26
    A.3Full title of the trial
    na
    Analgésie par le MEOPA (Mélange Equimolaire d’Oxygène et de Protoxyde d’Azote
    lors de la pose des sondes nasogastriques chez les enfants âgés de 3 mois à 3ans.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    na
    Etude « SONGER » (SOnde NasoGastrique Enfant pRotoxyde d’azote)
    A.3.2Name or abbreviated title of the trial where available
    SONGER
    SONGER
    A.4.1Sponsor's protocol code numberAPHP190210
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04008628
    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 SponsorAPHP
    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 supportAPHP
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPHP
    B.5.2Functional name of contact pointCORALIE VILLERET
    B.5.3 Address:
    B.5.3.1Street Address1 AV CLAUDE VELLEFAUX
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33140275266
    B.5.5Fax number33144 84 17 01
    B.5.6E-mailcoralie.villeret@aphp.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 Kalinox
    D.2.1.1.2Name of the Marketing Authorisation holderair liquide
    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.3.4Pharmaceutical form Gas for dispersion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation 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
    NA
    Déshydratations faibles à modérées
    E.1.1.1Medical condition in easily understood language
    NA
    Déshydratations faibles à modérées
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    NA
    Evaluer l’efficacité analgésique du MEOPA pour réduire la douleur induite par la pose de sonde nasogastrique chez des enfants âgés de 3 mois à 3 ans aux urgences pédiatriques
    E.2.2Secondary objectives of the trial
    NA
    - Evaluer l’anxiété des parents lors de la mise en place de la sonde nasogastrique : échelle graduée de 0 à 10.
    - Décrire les moyens de contentions utilisés : échelle de contention de l’enfant pour la pose de SNG
    - Déterminer les effets secondaires potentiels de l’utilisation du MEOPA dans cette indication : registre des effets indésirables.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    NA
    - Enfant âgé de 3 mois à 3 ans.
    - Hospitalisation aux urgences ou dans un lit d’aval
    - Prescription médicale de pose d’une sonde nasogastrique.
    - Enfant ayant une gastro-entérite et/ou une bronchiolite et/ou une intolérance alimentaire présentant une déshydratation légère à modérée
    - Présence d’un responsable de l’autorité parentale.
    - Consentement signé par un moins un responsable de l’autorité parentale
    E.4Principal exclusion criteria
    NA
    - Urgence vitale.
    - Parents refusent de participer à l’étude
    - Parents refusent d’être filmer ou que l’enfant soit filmé
    - Enfant déjà inclus dans l’étude ou en cours de participation à une autre étude.
    - Pose de sonde réalisée par un étudiant en médecine ou un étudiant infirmier.
    - Patient nécessitant une ventilation en oxygène pure.
    - Absence d’affiliation à la sécurité sociale
    - Antécédents d’intolérance de l’enfant au MEOPA (ayant présenté lors d’une utilisation précédente une sédation excessive ou une dépression respiratoire)
    - Enfant porteur d’un handicap mental ou de retard de développement connu
    - Enfant ayant eu un traumatisme crânien dans les 3 jours précédents

    E.5 End points
    E.5.1Primary end point(s)
    NA
    : le Kalinox® est administré au minimum 3 minutes au patient jusqu’à obtenir un effet anxiolytique et analgésique correct.
    E.5.1.1Timepoint(s) of evaluation of this end point
    : le Kalinox® est administré au minimum 3 minutes au patient jusqu’à obtenir un effet anxiolytique et analgésique correct.
    E.5.2Secondary end point(s)
    : le Kalinox® est administré au minimum 3 minutes au patient jusqu’à obtenir un effet anxiolytique et analgésique correct.
    E.5.2.1Timepoint(s) of evaluation of this end point
    : le Kalinox® est administré au minimum 3 minutes au patient jusqu’à obtenir un effet anxiolytique et analgésique correct.
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    na
    Analgésie
    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 No
    E.8.1.3Single blind Yes
    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
    soin sans analgésie
    na
    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 years
    E.8.9.1In the Member State concerned months12
    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 Yes
    F.1.1Number of subjects for this age range: 160
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 160
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 160
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    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
    sans
    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 Decision2020-01-14
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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