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    The EU Clinical Trials Register currently displays   43872   clinical trials with a EudraCT protocol, of which   7291   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:2007-007968-19
    Sponsor's Protocol Code Number:ET2007-073
    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:2008-04-03
    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 number2007-007968-19
    A.3Full title of the trial
    Evaluation comparative, en double aveugle, de l'efficacité d'infiltrations locales per et post opératoires de ropivacaïne dans la prise en charge de la douleur après chirurgie hépatique chez l'adulte
    A.3.2Name or abbreviated title of the trial where available
    DPO-Hépatectomie
    A.4.1Sponsor's protocol code numberET2007-073
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCENTRE LEON BERARD
    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 organisation
    B.5.2Functional name of contact point
    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 ROPIVACAÏNE (NAROPEINE )
    D.2.1.1.2Name of the Marketing Authorisation holderASTRA ZENECA
    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 nameROPIVACAÏNE
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    Infiltration 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboInfiltration use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients devant bénéficier d'une chirurgie hépatique
    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'efficacité d'infiltrations locales per et post opératoires (sur le site opératoire) de ropivacaïne versus sérum physiologique, sur la consommation de morphine par le patient au cours des 96 heures postopératoires
    E.2.2Secondary objectives of the trial
    - Evaluer l'efficacité de l'administration citée ci-dessus sur la consommation quotidienne de morphine par le patient, pendant les 4 jours suivant l'opération ;
    - Evaluer le ressenti de la douleur post-opératoire (DPO) par le patient au cours des 96 heures suivant l'opération ;
    - Evaluer les complications immédiates et tardives subies par le patient, liées à la perfusion du produit à l'étude, à la mise en place du DM, et aux autres effets secondaires prévisibles ;
    - Evaluer la réhabilitation postopératoire du patient ;
    - Evaluer la satisfaction du patient relative à la prise en charge de sa DPO.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Homme ou femme agé(e) de 18 ans ou plus
    - Atteint d'une tumeur maligne confirmée histologiquement
    - Devant subir une chirurgie d'hépatectomie en vue d'éxérèse de métastases hépatiques
    - Etat clinique < ou = 3 selon la classification ASA
    - Délai d'au moins 3 semaines entre chirurgie prévue et traitement par chimiothérapie de la maladie digestive
    - Paramètres fonctionnels hépatiques conformes aux valeurs suivantes : bilirubine totale < 1.5 fois LSN, ASAT et ALAT < 5 fois LSN
    - Paramètres fonctionnels rénaux conformes aux valeurs suivantes : créatinine < 115 micromol/l, clearance > 60 mm/h
    - Affiliation à un régime de SS
    - Consentement éclairé daté et signé
    - Capable de comprendre le français
    E.4Principal exclusion criteria
    - Carcinome hépatocellulaire ou une tumeur primitive du foie
    - Traitement par morphine de façon chronique ou douleur abdominale prééxistante
    - Intolérance ou une allergie aux morphiniques, aux anesthésiques locaux, au paracétamol, aux AINS ou aux corticoïdes
    - Pathologie sévère concomitante déstabilisée (insuffisance cardique, hépatique ou rénale)
    - Affection cardiovasculaire significative de type insuffisance cardiaque > classe 2 de la NYHA, IDM dans les 6 mois précédant la randomisation, angor instable, troubles du rythme graves, antécédents thromboemboliques sévères dans les 6 mois précédant la randomisation, allongement de l'intervalle QT, bradycardie, troubles électrolytiques, HTA non contrôlée par un traitement adapté
    - Antécédents documentés de troubles cognitifs ou psychaitriques ou comitialité
    - Femme enceinte ou allaitante
    - Patient privé de liberté par décision de justice ou administrative
    E.5 End points
    E.5.1Primary end point(s)
    - Consommation totale de morphine par kilogramme durant les 96h postopératoires
    - Consommation quotidienne de morphine par kilogramme, les 4 jours suivant l'intervantion chirurgicale
    - Ressenti de la DPO au cours des 96h suivant l'opération, investigué par la consommation d'autres antalgiques et l'intensité de la DPO objectivée toutes les 6h à l'aide d'une échelle visuelle analogique
    - Complications immédiates et tardives en lien avec l'administration du produit à l'étude, la mise en place du DM, les autres effets secondaires
    - Réhabilitation postopératoire, investiguée par : le délai de reprise du transit, le délai de réalimentation, le délai de mobilisation autonome, la durée moyenne de séjour
    - Recours aux système de soins le mois suivant l'opération
    - Satisfaction du patient relative à la prise en charge de sa DPO investiguée par un autoquestionnaire de satisfaction complété dans la demi-journée suivant le retrait du DM.
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    En ouvert pour la pharmacie
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 Information not present in EudraCT
    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
    Fin essai = fin du suivi du dernier patient inclus (suivi d'1 mois après sortie d'hospitalisation, soit un suivi total en moyenne de 6 semaines)
    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 months6
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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 Decision2008-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-17
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