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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42564   clinical trials with a EudraCT protocol, of which   7007   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
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    Summary
    EudraCT Number:2008-008140-25
    Sponsor's Protocol Code Number:P071231
    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:2009-06-22
    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 number2008-008140-25
    A.3Full title of the trial
    Evaluation de l'effet d'une infiltration péri-cicatricielle continue d'anesthésique local sur la zone d'hyperalgésie secondaire liée à la cicatrice d'extraction de pièce opératoire après colectomie coelioscopique (Etude CatCH)
    A.3.2Name or abbreviated title of the trial where available
    CATCH
    A.4.1Sponsor's protocol code numberP071231
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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.3.1Product nameNAROPEINE
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNaropeine
    D.3.9.3Other descriptive nameRopivocaine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2mg/ml
    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.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.2.1.1.1Trade name Xylocaine
    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.3.1Product nameXylocaine
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNXylocaine
    D.3.9.1CAS number 137-58-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 mg/ml
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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 injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Extraction de pièce opératoire après colectomie coelioscopique
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10056350
    E.1.2Term Nécessitant une Chirurgie abdominale
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparer l'infiltration continue péri-cicatricielle par cathéter multiperforé Painfusor de ropivocaïne (durant 48h) et de son placebo sur la surface de l'hyperalgésie secondaire mesurée 72 heures après initiation du traitement en tenant compte de l'effet éventuel de la résorption systémique des anesthésiques locaux.
    E.2.2Secondary objectives of the trial
    Effet de l'infiltration péri-cicatricielle continue sur :
    - les douleurs postopératoires au repos et à la mobilisation
    - la consommation postopératoire de morphine (administration contrôlée par patient)
    - le survenue d'une douleur persitante éventuelle, évaluée 3 à 6 mois après l'intervention
    - les effets de l'infiltration péricicatricille et ceux de la lidocaïne par voie intraveineuse sur la surface d'hyperalgésie secondaire mesurée 72h après l'initiation du traitement.
    - la réaction inflammatoire postopératoire
    - la réaction endocrino métabolique postopératoire
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Etude ancillaire dans le centre de Saint Antoine
    E.3Principal inclusion criteria
    Critères évalués à la veille de l'intervention
    - Patients de 18 à 80 ans
    - Classification I à III de l'American Society of Ansthesiologists (ASA)
    - Chirurgie colorectale par coelioscopie
    - Niveau de compréhension et d'expression ehn français satisfaisants
    - Signature de consentement après information par l'investigateur
    - Affiliation à un régime de sécurité sociale (bénéficiaire ou ayant droit).

    E.4Principal exclusion criteria
    - Absence de consentement
    - Grossesse connue ou allaitement
    - Existence de douleurs préopératoires chroniques
    - Coelioscopie exploratrice sans geste chirurgical associé
    - Consommation préopératoire d'opiacés, de corticoïdes, d'anti inflammatoire non stéroïdien ou de béta-bloqueur
    - Patient ayant reçu un antalgique dans les 48h précédant le début de l'étude
    - Intolérance connue à la lidocaïne, à la ropivocaïne ou à la morphine
    - Toxicomanie
    - Maladies inflammatoires du tube digestif (rectocolite hémorragique, maladie de Crohn)
    - Sepsis
    - Diabète de type I et II
    - Insuffisance cardiaque > au stade III et IV de la NYHA
    - Insuffisance hépatique sévère (TP<70% en l'absence d'anticoagulants)
    - Insuffisance rénale chronique (créatininémie >160micromol/L)
    - Anémie < 10 g/dl
    - Patient(e) traité(e) par médicaments pouvant interférer avec la lidocaïne (béta-bloquants, antiarythmique de toutes classes, inhibiteurs de la mono-amine oxydase non sélectifs (Moclamine°), sultopride (Barnetil°)
    - Intolérance connue à la lidocaïne, la ropivocaïne ou à la morphine
    - Patient(e) participant simultanément à un autre essai clinique ou en période d'exclusion.
    E.5 End points
    E.5.1Primary end point(s)
    Critère de jugement principal
    Ratio moyen de la surface d'hyperalgésie secondaire (en cm2) / la longueur de la cicatrice (en cm).
    Aire de la zone d'hyperalgésie mesuré au moyen de filaments de von Frey et exprimée sous forme du ratio [aire de la zone d'hyperalgésie péri-cicatricielle (cm2) / longueur de la cicatrice (cm)]
    Le critère de jugement principal sera évalué au 3ème jour (H+72), par un des investigateurs du centre à l'aveugle du traitement administré.

    Critères de jugement secondaires
    - Consommation totale de morphine (mg) (à H+24 et H+48)
    - Effet analgésique : échelle visuelle analogique
    - Ratio de la surface d'hyperagésie (en cm2) /la longueur de la cicatrice (en cm) (à H+120)
    - Influsence de l'administration intraveineuse de lidocaïne sur l'hyperalgésie secondaire postopératoire
    - Ratio moyen de la surface d'hyperalgésie (en cm2) /la longueur de la cicatrice (en cm) entre le groupe INFILTRATION (ropivocaïne) et le groupe IV (Lidocaïne)
    - Effet sur l'hypercatabolisme protidique: dosage de l'adrenaline, noradrenaline du glucagon, de l'insuline, du glucose, du cortisol et de l'ACTH plasmatique (à J0 : induction anesthésique, T0: mise en route de l'infiltration continue, H+8, H+24, H+48)
    -Effet sur la réaction inflammatoire: dosage de la CRP (C-Reactive-Protein) à J0, T0, H+8, H+24, H+48
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Modalités d'administration des médicaments, différentes
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state120
    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 Decision2009-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-24
    P. End of Trial
    P.End of Trial StatusOngoing
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