Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-001457-28
    Sponsor's Protocol Code Number:PI2018_843_0020
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2019-01-23
    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 number2018-001457-28
    A.3Full title of the trial
    Analgesic contribution of the suprazygomatic maxillary nerve block after cleft palate surgery in children
    Apport du bloc du nerf maxillaire par voie suprazygomatique dans l’analgésie après chirurgie de fente labiopalatine chez l’enfant
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Analgesic contribution of the suprazygomatic maxillary nerve block after cleft palate surgery in children
    Apport du bloc du nerf maxillaire par voie suprazygomatique dans l’analgésie après chirurgie de fente labiopalatine chez l’enfant
    A.3.2Name or abbreviated title of the trial where available
    Suprazyg
    Suprazyg
    A.4.1Sponsor's protocol code numberPI2018_843_0020
    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 Amiens-Picardie
    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 Amiens-Picardie
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Amiens-Picardie
    B.5.2Functional name of contact pointCOLLIN Arnaud
    B.5.3 Address:
    B.5.3.1Street AddressAmiens
    B.5.3.2Town/ cityAmiens
    B.5.3.4CountryFrance
    B.5.4Telephone number33322088371
    B.5.5Fax number33322089645
    B.5.6E-mailcollin.arnaud@chu-amiens.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 No
    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 namelevobupivacaine
    D.3.2Product code ATC N01B B10
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural 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
    cleft palate repair surgery with or without upper lip surgery
    chirurgie fente palatine ou vélo-palatine, associée ou non à une fente labiale, uni ou bilatérale
    E.1.1.1Medical condition in easily understood language
    cleft palate repair surgery with or without upper lip surgery
    chirurgie fente palatine ou vélo-palatine, associée ou non à une fente labiale, uni ou bilatérale
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    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
    compare the consumption of morphine during the first 48 hours after cleft palate surgery in a group of patients treated by realization of a suprazygomatic maxillary nerve block, compared to a control group
    évaluer l’apport du bloc du nerf maxillaire par voie suprazygomatique dans l’analgésie après chirurgie de correction de fente palatine
    E.2.2Secondary objectives of the trial
    To compare between two groups:
    • the evaluation of the consumption of perioperative morphine
    • the evaluation of the scales of pain at different defined times
    • the evaluation of the number of episodes of respiratory distres
    • the evaluation of the period of re-feeding
    • the evaluation of the duration of hospitalization
    • the complications due to nerve block
    comparer entre les 2 groupes :
    • la consommation de morphiniques per opératoires,
    • les échelles de douleurs à différents temps définis,
    • le nombre d’épisodes de détresse respiratoire,
    • le délai de réalimentation,
    • la durée de séjour,
    • les complications liées à la réalisation du bloc
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    children between 6 month and 12yo (>5kg) undergoing cleft palate repair surgery with or without upper lip surgery
    Patients présentant une fente palatine ou vélo-palatine, associée ou non à une fente labiale, uni ou bilatérale
    Patients âgés de plus de 6 mois et de moins de 12 ans
    Poids supérieur à 5kg
    Obtention préalable du consentement parental
    Bénéficiaire d’un régime de sécurité sociale
    E.4Principal exclusion criteria
    inappropriate age, weight <5kg, abnormal blood coagulation, local anesthetic contraindication, local infection.
    Patients dont le bilan sanguin pré opératoire est anormal ou non réalisé
    Patients présentant un trouble de la coagulation
    Patients âgés de moins de 6 mois et de plus de 13 ans
    Patients pesant moins de 5kg
    Patients présentant une contre-indication aux AL
    Patients présentant une infection au point de ponction
    Patients placés sous sauvegarde de justice
    E.5 End points
    E.5.1Primary end point(s)
    amount of morphine consumed during the 48 hours post surgery
    quantité de morphine consommée pendant les 48 heures post opératoires
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours postoperative
    48 heures post opératoires
    E.5.2Secondary end point(s)
    - amount of morphine consumed during the surgery
    - scales of pain at different defined times,
    - the number of episodes of respiratory distress,
    - the feed time,
    - the length of stay
    - la consommation de morphiniques per opératoires,
    - les échelles de douleurs à différents temps définis,
    - le nombre d’épisodes de détresse respiratoire,
    - le délai de réalimentation,
    - la durée de séjour.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between the surgery and 30 days after the surgery
    Du jour de l'opération jusqu'à la visite à 30 jours post-opératoires
    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) 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 Yes
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    pas d'anesthésie loco-régionale
    no regional loco anesthesia
    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
    Dernière visite du dernier patient inclus
    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 Yes
    F.1.1Number of subjects for this age range: 74
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 37
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 37
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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 state74
    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)
    normal post surgery followed
    suivi post-opératoire classique
    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 Decision2019-05-10
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 23:21:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA