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    Summary
    EudraCT Number:2017-003638-10
    Sponsor's Protocol Code Number:2016_37
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2018-01-12
    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 number2017-003638-10
    A.3Full title of the trial
    INTRANASAL CLONIDINE PREDICTION IN PEDIATRIC SURGERY: RANDOMIZED STUDY AGAINST PLACEBO
    PREMEDICATION PAR CLONIDINE INTRANASALE EN CHIRURGIE
    PEDIATRIQUE : ETUDE RANDOMISEE CONTRE PLACEBO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    INTRANASAL CLONIDINE PREDICTION IN PEDIATRIC SURGERY: RANDOMIZED STUDY AGAINST PLACEBO
    PREMEDICATION PAR CLONIDINE INTRANASALE EN CHIRURGIE
    PEDIATRIQUE : ETUDE RANDOMISEE CONTRE PLACEBO
    A.3.2Name or abbreviated title of the trial where available
    CLONIPREM
    CLONIPREM
    A.4.1Sponsor's protocol code number2016_37
    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 SponsorCHRU 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 supportCHRU DE LILLE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationchru de lille
    B.5.2Functional name of contact pointAbdeljalil AKCHICH
    B.5.3 Address:
    B.5.3.1Street Address2 avenue oscar lambret
    B.5.3.2Town/ citylille
    B.5.3.3Post code59037
    B.5.3.4CountryFrance
    B.5.4Telephone number00330320444145
    B.5.5Fax number00330320445711
    B.5.6E-mailDRC@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 CATAPRESSAN solution injectable Clonidine
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM FRANCE
    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 Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for injection
    D.8.4Route of administration of the placeboPerineural use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    intra-nasal premedication instead of oral, intravenous or no
    premedication.
    prémédication en intra-nasal au lieu de orale, intra-veineuse ou pas de
    prémédication
    E.1.1.1Medical condition in easily understood language
    intra-nasal premedication instead of oral, intravenous or no
    premedication.
    prémédication en intra-nasal au lieu de orale, intra-veineuse ou pas de
    prémédication
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10042609
    E.1.2Term Surgery
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to evaluate the efficacy of intranasal clonidine vs placebo in premedication in pediatric surgery on anxiolytic separation with parents.
    l'objectif principal de cette étude est d'évaluer l'efficacité de la clonidine intranasale vs placebo en prémédication en chirurgie pédiatrique sur l'anxiolyse lors de la séparation avec les parents.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate the efficacy of
    intranasal clonidine on anxiolysis at induction and on awakening, as well as the undesirable effects of premonication with clonidine.
    les objectifs secondaires de cette étude sont d'évaluer l'efficacité de la clonidine intranasale sur l'anxiolyse au moment de l'induction et au réveil, ainsi que les effets indésirables d'une prémédication par
    clonidine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age of 1 to 5 years,
    - Weight from 10 to 25 kg
    - Signature of informed consent
    - ASA 1 or 2, (ANNEX 6)
    - Scheduled minor surgery
    - Affiliation to Social Security
    - Age de 1 à 5 ans,
    - Poids de 10 à 25 kg
    - Signature du consentement éclairé
    - ASA 1 ou 2, (ANNEXE 6)
    - Chirurgie mineure programmée
    - Affiliation à la sécurité sociale
    E.4Principal exclusion criteria
    - Failure to obtain consent,
    - Participation in another clinical trial involving a drug,
    - Known contraindications or hypersensitivity to clonidine, or to any of
    the excipients,
    - Upper airway infection within 3 weeks prior to inclusion,
    - Intravenous Induction,
    - History of cardiac arrhythmia, congenital heart disease,
    - Mental retardation or psychoactive treatment.
    - Défaut d'obtention du consentement,
    - Participation à un autre essai clinique portant sur un médicament,
    - Contre-indications ou hypersensibilité connue à la clonidine, ou à l'un
    des excipients,
    - Infection des voies aériennes supérieures dans les 3 semaines
    précédant l'inclusion,
    - Induction intraveineuse,
    - Antécédent d'arythmie cardiaque, cardiopathie congénitale,
    - Retard mental ou traitement psychoactif.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is:
    The anxiolytic score at 30 min after administration of premedication ie at
    the time of separation with the parents.
    The anxiolyse will be defined by a score greater than or equal to 3.
    Le critère principal d'évaluation est :
    le score d'anxiolyse à 30 min après administration de la prémédication
    c'est-à-dire au moment de la séparation avec les parents.
    L'anxiolyse sera définie par un score supérieur ou égal à 3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 min after administration of premedication ie at the time of
    separation with the parents
    30 min après administration de la prémédication c'est-à-dire au moment
    de la séparation avec les parents.
    E.5.2Secondary end point(s)
    The secondary evaluation criteria are:
    - the acceptance of the mask at the induction of anesthesia,
    The postoperative agitation measured by the anxiolytic score 15 min
    after extubation and at the exit of SSPI,
    - the presence of adverse effects on the respiratory rate, defined by a value lower than the norm
    - the presence of a desaturation defined by an SpO2 value of less than or
    equal to 94% for more than 30 seconds
    - the presence of undesirable effects on the heart rate, defined by a
    value higher or lower than the norm
    - the tolerance of intranasal administration. Intolerance of
    administration will be defined by crying of the child, a burning sensation
    or a bitter taste to the administration of the product.
    - the existence of postoperative behavior disorders on D1 and D7,
    defined by a score PHBQ> 68.
    - an increase in the time between the withdrawal of sevoflurane and
    extubation
    - the need to administer morphine in the recovery room
    - the need for analgesics other than paracetamol in postoperative care
    Les critères secondaires d'évaluation sont :
    - l'acceptation du masque à l'induction de l'anesthésie,
    - l'agitation post opératoire mesurée par le score d'anxiolyse 15min
    après extubation et à la sortie de SSPI,
    - la présence d'effets indésirables sur la fréquence respiratoire, définie
    par une valeur inférieure à la norme
    - la présence d'une désaturation définie par une valeur de SpO2
    inférieure ou égale à 94% pendant plus de 30 secondes
    - la présence d'effets indésirables sur la fréquence cardiaque, définie par
    une valeur supérieure ou inférieure à la norme
    - la tolérance de l'administration intranasale. L'intolérance de
    l'administration sera définie par des pleurs de l'enfant, une sensation de
    brûlure ou un goût amer à l'administration du produit.
    - l'existence de troubles du comportement post opératoires à J1 et à J7,
    définie par un score PHBQ > 68.
    - un allongement du délai entre l'arrêt du sévoflurane et l'extubation
    - la nécessité d'administration de morphiniques en salle de réveil
    - la nécessité d'administration d'antalgiques autres que le paracétamol
    en post opératoire
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the induction of the anesthesia, 15 min after extubation and at the
    exit of SSPI, J1 and at J7 post-operative.
    A l'induction de l'anesthésie, 15 min après extubation et à la sortie de
    SSPI, J1 et à J7 post-opératoire.
    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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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
    it is the last visit of the last subject.
    il s'agit de la dernière visite du dernier patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 Yes
    F.1.1Number of subjects for this age range: 150
    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: 30
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 120
    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 state150
    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
    Aucun
    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 Decision2017-12-22
    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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