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    Summary
    EudraCT Number:2014-002044-41
    Sponsor's Protocol Code Number:38RC14.176
    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:2015-06-18
    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 number2014-002044-41
    A.3Full title of the trial
    ROpivacaïne par cathéter cicatriciel versus Morphine épidurale dans l’ANalgésie après Césarienne En cours de travail.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Anesthésie locale cicatricielle versus morphine péridurale pour la gestion de la douleur après césarienne non programmée
    A.3.2Name or abbreviated title of the trial where available
    ROMANCE
    A.4.1Sponsor's protocol code number38RC14.176
    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 SponsorUniversity Hospital of Grenoble
    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 supportUniversity Hospital of grenoble
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportAPICIL
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportSociete Baxter SAS
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportSociete Districlass medical SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationpôle Anesthésie Réanimation
    B.5.2Functional name of contact pointDr Thomas DECARPENTRIES
    B.5.3 Address:
    B.5.3.1Street AddressCHU de Grenoble
    B.5.3.2Town/ cityGrenoble
    B.5.3.3Post code38043
    B.5.3.4CountryFrance
    B.5.4Telephone number0033671622995
    B.5.5Fax number00330476765183
    B.5.6E-mailTDecarpentries@chu-grenoble.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 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 injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    Infiltration
    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 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.2.1.1.1Trade name Morphine Aguettant
    D.2.1.1.2Name of the Marketing Authorisation holderAguettant
    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 injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpidural 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
    césarienne non programmée en cours de travail, sous anesthésie péridurale.
    E.1.1.1Medical condition in easily understood language
    césarienne non programmée sous anesthésie péridurale.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    L’hypothèse est que l’analgésie par infiltration continue de ropivacaïne via un cathéter cicatriciel permet d’obtenir une analgésie comparable à celle procurée durant 24 heures par l’injection unique de 2 mg de morphine dans l’espace péridural, cela dans le cadre d’une analgésie multimodale incluant la prise systématique de paracétamol et de kétoprofène.
    E.2.2Secondary objectives of the trial
    - Montrer une réduction des effets secondaires liés à l’analgésie : prurit, nausées, vomissements, durée de sondage urinaire, et délais de reprise de transit intestinal (1ère selle).
    - Rechercher des douleurs ou difficultés au retrait du cathéter cicatriciel.
    - Comparaison de l’analgésie de repos fournie dans les 2 groupes à H2, H6, H12, H24, et H48.
    - Comparaison de l’analgésie de mobilisation fournie dans les 2 groupes à H2, H6, H12, H48.
    - Evaluation de la satisfaction maternelle à H 48 sur l’analgésie procurée, le délais de mise au sein et le succès de la première tétée.
    - Comparaison de la réhabilitation via les durées d’hospitalisations dans les deux groupes.
    - Evaluation de la douleur résiduelle à 3 mois
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patientes ASA 1 et 2
    - Césarienne non programmée en cours de travail, sous anesthésie péridurale
    - Cathéter de péridurale préexistant et fonctionnel avant la décision de césarienne
    - Incision sus-pubienne
    E.4Principal exclusion criteria
    - Patientes ASA 3 et 4
    - Diabète, obésité (BMI > 30)
    - Contre-indication à un des traitements utilisés dans l’étude (paracétamol, AINS, ropivacaïne, morphine)
    - Douleur chronique préexistante
    - Notion de consommation excessive de morphinomimétiques (douleur chronique, toxicomanie)
    - Patiente qui, selon l’avis de l’investigateur, ne serait pas apte à se conformer aux modalités de la recherche pendant 3 mois.
    E.5 End points
    E.5.1Primary end point(s)
    EVA de mobilisation à H24. La mobilisation est celle nécessaire pour passer de la position allongée à la position semi-assise.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 heures
    E.5.2Secondary end point(s)
    - EVA de repos à H2, H6, H12, H24, H48
    - EVA de mobilisation à H2, H6, H12, H48
    - Présence de nausées, vomissements, prurit à H2, H6, H12, H24, H48
    - Durée de sondage urinaire
    - Délais de reprise de transit intestinal (première selle)
    - Doses de morphiniques supplémentaires éventuellement reçues (titration morphine en SSPI puis actiskénan dans le service).
    - Douleur ou difficultés au retrait du cathéter cicatriciel
    - Score de satisfaction maternelle (allant de 0 à 10) : satisfaction sur l’analgésie reçue, succès de la première tétée
    - Délais première mise au sein
    - Durée hospitalisation
    - Douleur résiduelle (EN) aux mobilisations à 3 mois par entretien téléphonique
    E.5.2.1Timepoint(s) of evaluation of this end point
    H2, H6, H12, H24, H48 et à 3 mois
    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 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 No
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    Morphine
    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
    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 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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    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 No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.6.1Details of subjects incapable of giving consent
    femmes nécessitant une césarienne non programmée lors de leur accouchement
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state110
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 110
    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 Decision2014-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-15
    P. End of Trial
    P.End of Trial StatusOngoing
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