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    Summary
    EudraCT Number:2015-000189-71
    Sponsor's Protocol Code Number:RBHP2015BAZIN
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-06-03
    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 number2015-000189-71
    A.3Full title of the trial
    .
    Comparaison des concentrations plasmatiques pour une anesthésie optimale chez les obèses et les non obèses
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    .
    .
    A.3.2Name or abbreviated title of the trial where available
    .
    COCOPOPONO
    A.4.1Sponsor's protocol code numberRBHP2015BAZIN
    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 de Clermont-Ferrand
    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 supportCHU Clermont-Ferrand
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Clermont-Ferrand
    B.5.2Functional name of contact pointDélégation à la Recherche Clinique
    B.5.3 Address:
    B.5.3.1Street Address58 rue Montalembert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number003304 73751195
    B.5.5Fax number003304 73754730
    B.5.6E-mailplacarin@chu-clermontferrand.fr
    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.2.1.2Country 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 namePropofol
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROPOFOL LIPURO 2 % (20 mg/ml), émulsion injectable ou pour perfusion
    D.3.9.1CAS number 570 528-3:
    D.3.9.3Other descriptive namePROPOFOL
    D.3.9.4EV Substance CodeSUB10116MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg/h milligram(s)/kilogram/hour
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4 to 12
    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.IMP: 2
    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.2.1.2Country 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 nameRemifentanil
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREMIFENTANIL
    D.3.9.1CAS number 132875-61-7
    D.3.9.4EV Substance CodeSUB10272MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg/h milligram(s)/kilogram/hour
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.006 to 0.06
    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
    .
    Patient majeur devant bénéficier d’une anesthésie générale pour chirurgie laparoscopique sus-mésocolique (chirurgie bariatrique ou cholécystectomie).
    Pour le groupe « obèses » patient avec obésité sévère : 35kg/m2≤IMC<45kg/m2
    E.1.1.1Medical condition in easily understood language
    .
    Patient majeur devant bénéficier d’une anesthésie générale pour chirurgie laparoscopique sus-mésocolique.
    Pour le groupe « obèses » patient avec obésité sévère
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10018061
    E.1.2Term General anesthesia
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    .
    L’objectif principal de cette étude est de déterminer si pour un effet cible comparable (analgésie et sédation monitorées), les concentrations plasmatiques en propofol et rémifentanil nécessaires au cours de la phase d’entretien d’une anesthésie générale pour stimulus chirurgical comparable sont les mêmes dans une population de patients obèses et non obèse.
    E.2.2Secondary objectives of the trial
    .
    - Déterminer si pour un effet cible comparable (analgésie et sédation monitorées), les débits massiques d’administration de propofol et rémifentanil nécessaires au cours de la phase d’entretien d’une anesthésie générale pour stimulus chirurgical comparable sont les mêmes dans une population de patients obèses et non obèse.

    - Comparer les concentrations plasmatiques en propofol et rémifentanil au cours de la phase d’induction et de réveil d’une anesthésie générale dans une population de patients obèses et non obèse.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    .
    • Age > 18 ans
    • Patients bénéficiant d’une anesthésie générale pour chirurgie laparoscopique sus-mésocolique (chirurgie bariatrique ou cholécystectomie).
    • Patients ayant donné leur consentement selon les modalités décrites par la loi de santé publique du 9 Aout 2004.
    • Patients bénéficiant d’un régime de Sécurité Sociale.
    Groupe obèse :
    • Patients obèses sévères et morbides (35kg/m2≤IMC<45kg/m2).
    E.4Principal exclusion criteria
    .
    • Refus du patient
    • Age <18 ans
    • Majeurs protégés et personnes vulnérables
    • Pace maker
    • Anesthésie générale dans les 24 heures précédant la présente intervention chirurgicale
    • Dysautonomie avérée ou suspectée
    • Prémédication par gabapentine Neurontin°
    • Technique d’analgésie locorégionale péri-médullaire utilisée de façon concomitante à la période pré et peropératoire.
    • Cardiopathie dysrythmique non équilibrée (AC/FA ; extrasystoles ; rythme non sinusal)
    • Femme enceinte ou allaitant
    • BMI<35kg/m2 ou >45kg/m2
    • Intubation impossible prevue
    • Hypersensibilité aux produits utilisés
    • Allergie à l’arachide ou au soja
    E.5 End points
    E.5.1Primary end point(s)
    .
    Taux plasmatiques du Remifentanil et Propofol aux différents temps de la phase d’entretien de anesthésie générale :

    E.5.1.1Timepoint(s) of evaluation of this end point
    .
    T5 : 5 minutes après l’insufflation du pneumopéritoine.
    T6 : 5 minutes après réalisation de la tranche gastrique ou ligature des voies biliaires.
    T7 : à l’extraction de la pièce.
    T8 : à l’exsufflation du pneumopéritoine.
    T9 : au dernier point cutané.
    E.5.2Secondary end point(s)
    .
    Les débits d’administration sont relevés aux différents temps d’une anesthésie générale pour chirurgie laparoscopique sus-mésocolique, qui sont les mêmes que ceux des prélèvements présentés dans le "Primary end point".

    Les taux plasmatiques du Remifentanil et Propofol aux différents temps des phases d’induction et de réveil d’une anesthésie générale :

    T0 : avant administration de tout produit anesthésique.
    T1 : à 1 minute après la fin de l’induction.
    T2 : à 3 minutes après la fin de l’induction.
    T3 : à 6 minutes après la fin de l’induction.
    T4 : à 10 minutes après la fin de l’induction.
    E.5.2.1Timepoint(s) of evaluation of this end point
    .
    T0 : avant administration de tout produit anesthésique.
    T1 : à 1 minute après la fin de l’induction.
    T2 : à 3 minutes après la fin de l’induction.
    T3 : à 6 minutes après la fin de l’induction.
    T4 : à 10 minutes après la fin de l’induction.
    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 Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    Etude Cas témoin
    .
    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
    Patients non obèses
    .
    E.8.2.4Number of treatment arms in the trial2
    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
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 state40
    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 Decision2015-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-09
    P. End of Trial
    P.End of Trial StatusOngoing
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