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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2008-004738-25
    Sponsor's Protocol Code Number:CHUBX 2007/26
    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:2008-08-22
    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 number2008-004738-25
    A.3Full title of the trial
    Etude des effets d’une infiltration continue péristernale de ropivacaïne sur l’hypersensibilité à la douleur consécutive à une sternotomie en chirurgie cardiaque
    A.3.2Name or abbreviated title of the trial where available
    CARDIODOLAL
    A.4.1Sponsor's protocol code numberCHUBX 2007/26
    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 SponsorCHU de Bordeaux
    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 Naropeine
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInfiltration 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
    Chirurgie cardiaque avec sternotomie médiane
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10051501
    E.1.2Term Sternotomy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer, chez les patients bénéficiant d’une chirurgie cardiaque par sternotomie, l’efficacité de la ropivacaïne administrée en per et post-opératoire, à réduire la distance (en cm) de l’hyperalgésie dynamique, le premier jour post-opératoire, ue en zone périphérique de sternotomie.
    E.2.2Secondary objectives of the trial
    - Evaluer de l’efficacité de la ropivacaïne administrée en per, et postopératoire sur l’hyperalgésie statique postopératoire zone périphérique de sternotomie,
    - Evaluer les taux plasmatiques de ropivacaïne (µg/ml) dans le groupe 1 lorsque l’on administre une perfusion continue,
    - Evaluer la consommation de morphine (mg) en Analgésie Contrôlée par le Patient (ACP) (dose totale sur 48 heures incluant la dose de morphine titrée en réanimation), le recours à d’autres antalgiques (Kétoprofène, boli de morphine) durant la période d’évaluation, et l’évaluation des fonctions respiratoires (peak flow en l/min) après l’intervention par sternotomie,
    - Evaluer la douleur post-opératoire au repos et à l’effort par les échelles de douleur (EVA et EVS), toutes les 4 heures pendant 48 heures,
    - Evaluer l’incidence des douleurs chroniques par un questionnaire téléphonique spécifique à 6 mois
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age compris entre 50 et 75 ans
    - Score ASA (American Society of Anesthesiology) : 1-3
    - Chirurgie cardiaque avec sternotomie médiane pour :
    - changement valvulaire unique ou Bentall ou Banhson ou Tyrone David,
    - pontage aorto-coronarien simple ou multiple,
    - chirurgie mixte (remplacement valvulaire + pontage aorto-coronarien),
    - sans complication prévisible décelée en pré-opératoire.
    - Consentement libre, éclairé et écrit signé par le patient et l’investigateur (au plus tard le jour de l’inclusion et avant tout examen nécessité par l’étude)
    - Sujet affilié ou bénéficiaire d’un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Refus du patient de participer à l’étude
    - Histoire de toxicomanie et/ou alcoolisme chronique sevrée ou actuelle
    - Prise d’antalgiques et/ou morphiniques dans les 12 heures avant chirurgie
    - Prise chronique d’antalgiques et/ou patient douloureux chronique > 3 mois
    - Patient incapable d’utiliser ou de comprendre le fonctionnement d’une PCA
    - Allergie au produit utilisé (ropivacaïne) ou à d’autres anesthésiques locaux à liaison amide
    - Patient traité par fluvoxamine (antidépresseur) ou énoxamine (antibiotique)
    - Patient présentant une insuffisance hépatique (score de child-pugh >A)
    - Patient présentant une hypovolémie préopératoire majeure (signes cliniques de déshydratation : pli cutané, langue rotie, hypotonie des globes oculaires, TAS<100mmHg, deltaPP supérieur à 25%),
    - Personnes placées sous sauvegarde de justice
    - Reprise chirurgicale avant l’évaluation du critère principal de jugement à J1.
    E.5 End points
    E.5.1Primary end point(s)
    Différence de la distance d’hyperalgésie (cm) en zone péricicatricielle entre le groupe recevant le placebo (groupe 2) et celui recevant la ropivacaïne en per et postopératoire (groupe 1) à la 24°heure (J1) post-opératoire. La distance d’hyperalgésie sera définie comme la distance entre le milieu de la ligne d’incision et le point hyperalgésique le plus éloigné de celle-ci, sur une ligne perpendiculaire. La mesure sera effectuée de façon dynamique en ramenant le filament de Von Frey 100g au contact de l’épiderme du patient depuis une distance de 10 cm à droite de la ligne d’incision en suivant une ligne perpendiculaire passant au centre de celle-ci.
    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 Yes
    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) 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 No
    E.8.1.4Double blind Yes
    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 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
    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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 state40
    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 Decision2008-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-13
    P. End of Trial
    P.End of Trial StatusOngoing
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