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    The EU Clinical Trials Register currently displays   37236   clinical trials with a EudraCT protocol, of which   6125   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-001603-23
    Sponsor's Protocol Code Number:RBHP_2016_FUTIER
    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:2016-10-24
    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 number2016-001603-23
    A.3Full title of the trial
    .
    Administration individualisée de sufentanil guidée sur la mesure de Analgesia Nociception Index (ANI) par rapport au standard de soin en chirurgie abdominale majeure : étude randomisée contrôlée de faisabilité
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    .
    .
    A.3.2Name or abbreviated title of the trial where available
    .
    PHOENIX
    A.4.1Sponsor's protocol code numberRBHP_2016_FUTIER
    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 de Clermont-Ferrand
    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 de Clermont-Ferrand
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Clermont-Ferrand
    B.5.2Functional name of contact pointInvestigateur Principal
    B.5.3 Address:
    B.5.3.1Street Address1 Place Lucie et Raymond Aubrac
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number0033473750476
    B.5.5Fax number0033473750500
    B.5.6E-mailefutier@chu-clermontferrand.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 SUFENTANIL
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN SAS
    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 nameSUFENTANIL
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNSUFENTANIL CITRATE
    D.3.9.1CAS number 60561-17-3
    D.3.9.4EV Substance CodeSUB04616MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µl/ml microlitre(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    .
    Patient majeur, devant bénéficié d'une chirurgie abdominale réglée dont la durée estimée est supérieure à 2 heures
    E.1.1.1Medical condition in easily understood language
    .
    Patient majeur, devant bénéficié d'une chirurgie abdominale réglée dont la durée estimée est supérieure à 2 heures
    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
    .
    Déterminer si le maintien d’une cible thérapeutique d’ANI comprise entre 50 à 70 (pour une énergie comprise entre 0,05 et 2,5) lors de l’administration sufentanil en perfusion continue par rapport au standard de soin permet de diminuer la quantité de sufentanil en per opératoire de chirurgie digestive.
    E.2.2Secondary objectives of the trial
    .
    •Déterminer si l’administration individualisée de sufentanil guidée par le monitorage de l’ANI permet :
    - de rester plus de 50% du temps opératoire dans la cible thérapeutique (cible thérapeutique de 50 à 70 ; pour une énergie comprise entre 0,05 et 2,5).

    - de rester plus de 50% de temps supplémentaire dans la cible thérapeutique par rapport à l’administration conventionnelle.

    - permet de réduire le nombre d’hypoxémie post opératoire précoce.

    - permet de réduire le délai d’extubation après chirurgie.

    - permet de limiter l’incidence de recours à une oxygénothérapie postopératoire en SSPI.

    - permet de procurer une meilleure analgésie post-opératoire du patient en SSPI (évaluée par échelle visuelle numérique).

    - permet de réduire la quantité de morphiniques administrée en postopératoire en SSPI.

    - permet de réduire le délai nécessaire à l’obtention d’un score d’Aldrete >9.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    .
    - Âge > 18 ans
    - Chirurgie abdominale réglée
    - Durée estimée de la chirurgie supérieure à 2 heures
    - Ayant donné leur consentement selon les modalités décrites par la loi de santé publique du 9 août 2004.
    - Affilié à un régime de sécurité sociale
    E.4Principal exclusion criteria
    .
    - Refus de participation du patient
    - Chirurgie en urgence vitale
    - Arythmie cardiaque par fibrillation auriculaire
    - Port d’un Pacemaker
    - Patient greffé cardiaque
    - Prévision d’une anesthésie neuraxiale parpératoire
    - Pathologie pouvant fausser l’interprétation de la mesure de SpO2 (ex : methémoglobinémie)
    - Obésité morbide (définit par un IMC > 35 kg/m2)
    - Syndrome d’apnée du sommeil, appareillé ou non
    - Personne sous tutelle ou curatelle
    - Grossesse
    - Allaitement
    E.5 End points
    E.5.1Primary end point(s)
    .
    Dose totale de sufentanil en peropératoire de chirurgie abdominale..
    E.5.1.1Timepoint(s) of evaluation of this end point
    .
    à H12, H0 étant le début de l'intervention chirurgicale
    E.5.2Secondary end point(s)
    .
    - Pourcentage de temps peropératoire passé dans la cible thérapeutique (cible thérapeutique de 50 à 70 ; pour une énergie comprise entre 0,05 et 2,5).

    - Nombre de patients présentant une hypoxémie postopératoire précoce (définie par une SpO2 < 92% en air ambiant mais répondant à une administration d’oxygène par canule nasale ou masque facial).

    - Délai entre l’arrêt d’administration du sufentanil (définit par le début de la fermeture cutanée) et l’extubation trachéale du patient.

    - Taux de patients bénéficiant d’une oxygénothérapie postopératoire en SSPI.

    - Score de douleur postopératoire, évaluée par échelle visuelle numérique (E.V.N.) au repos et à l’effort une heure après extubation, en sortie de SSPI.

    - La dose totale de morphinique administrée en SSPI.

    - Délai entre l’arrêt d’administration du sufentanil et l’obtention d’un score d’ Aldrete > 9 (définissant la possibilité de sortie de SSPI).
    E.5.2.1Timepoint(s) of evaluation of this end point
    .
    à H48, H0 étant le début de l'intervention chirurgicale
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sufentanil mais dont la posologie est guidée sur la mesure de "l'Analgesia Nociception Index"
    .
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    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
    LVLS
    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 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.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state120
    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)
    .
    La prise en charge des patients, lorsqu'ils ont terminé l'étude
    correspond à la prise en charge habituelle de tout patient atteint par
    cette pathologie.
    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 Decision2016-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-20
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