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    Summary
    EudraCT Number:2017-003564-12
    Sponsor's Protocol Code Number:DOUSSOT-AOI-2017
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-09-13
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-003564-12
    A.3Full title of the trial
    IMPACT D’UN FLASH PREOPERATOIRE DE CORTICOÏDES SUR LA MORBIDITE APRES RESECTION COLORECTALE : ETUDE PILOTE PROSPECTIVE MONOCENTRIQUE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact sur la morbidité de l'administration d'une forte dose unique de corticoïdes au moment de l'anesthésie lors d'une chirurgie colorectale
    A.3.2Name or abbreviated title of the trial where available
    Corticolon
    A.4.1Sponsor's protocol code numberDOUSSOT-AOI-2017
    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 SponsorCHU Dijon Bourgogne
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Dijon Bourgogne
    B.5.2Functional name of contact pointChef de projets recherche
    B.5.3 Address:
    B.5.3.1Street Address1, Boulevard Jeanne d'Arc
    B.5.3.2Town/ cityDijon
    B.5.3.3Post code21079
    B.5.3.4CountryFrance
    B.5.6E-mailmarion.cortier@chu-dijon.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 METHYLPREDNISOLONE
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN
    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 Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    Chirurgie colorectale élective
    E.1.1.1Medical condition in easily understood language
    Chirurgies du côlon et du rectum
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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
    Evaluer l’impact de la corticothérapie en flash préopératoire sur la survenue de complications postopératoires majeures à J30 (> grade 2 Dindo-Clavien).
    E.2.2Secondary objectives of the trial
    Evaluer l’intérêt de la corticothérapie en flash préopératoire sur :
    *la fréquence de complications infectieuses intraabdominales à J30.
    *la fréquence de complications infectieuses générales à J30.
    *la durée moyenne de séjour.
    *la fréquence de réadmission hospitalière à J30.
    Etudier la tolérance de la corticothérapie en flash préopératoire
    Etudier la cinétique des marqueurs de l’inflammation et de l’endotoxémie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient majeur
    - Patient bénéficiant d’une chirurgie colorectale élective (maladie diverticulaire, tumeur bénigne ou maligne, maladie inflammatoire intestinale, rétablissement de continuité, endométriose ou autre)
    - Chirurgie avec rétablissement de continuité immédiat, avec ou sans stomie de protection.
    - Patient ayant reçu l’information portant sur la recherche, avec capacité de compréhension correcte et ayant donné son consentement.
    E.4Principal exclusion criteria
    - Adulte protégé
    - Patient non affilié à un régime de sécurité sociale
    - Femme enceinte ou allaitante
    - Résection colorectale avec chimiothérapie hyperthermique intrapéritonéale concomitante
    - Patient sous corticothérapie au long cours
    - Natrémie préopératoire > 147 mmol/L
    - Kaliémie < 3,3 mmol/L
    - Patient présentant une contre-indication au traitement par Methylprednisolone Mylan® :
    o une infection active
    o une virose en évolution (notamment hépatites, herpès, varicelle, zona),
    o un état psychotique encore non contrôlé par un traitement,
    o une hypersensibilité à la méthylprednisolone ou à l’un des excipients de la spécialité Methylprednisolone Mylan®
    E.5 End points
    E.5.1Primary end point(s)
    Fréquence de complications postopératoires majeures, survenant jusqu’au 30ème jour postopératoire (J30), et définies comme toutes les complications avec un grade supérieur à II selon la classification de Dindo-Clavien.
    E.5.1.1Timepoint(s) of evaluation of this end point
    J30 postopératoire
    E.5.2Secondary end point(s)
    1) Fréquence de complications infectieuses intraabdominales, dont les fistules anastomotiques, à J30 selon la définition des CDC (Centres for Disease Control and Prevention).
    2) Fréquence de complications infectieuses générales à J30 selon la définition des CDC (Centres for Disease Control and Prevention).
    3) Nombre de jours d’hospitalisation. En cas de décès, le patient sera considéré comme ayant été hospitalisé jusqu’à J30.
    4) Fréquence de réadmission hospitalière à J30.
    5) Tolérance à l’injection de corticoïdes : survenue d’hyperglycémie et ou de troubles ioniques (type dyskaliémie).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) J30 postopératoire
    2) J30 postopératoire
    3) J30 postopératoire
    4) J30 postopératoire
    5) per et postopératoire
    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 Yes
    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) 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 Yes
    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
    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 months14
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-09-13. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state109
    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 Decision2017-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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