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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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:2020-000087-26
    Sponsor's Protocol Code Number:2019/09
    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:2020-02-26
    Trial results View 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 number2020-000087-26
    A.3Full title of the trial
    Time to transit Recovery After treatment with Naloxegol in cardiac Surgery Intensive care Trial
    Intérêt du Naloxégol dans la reprise du transit en postopératoire de chirurgie cardiaque
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Time to transit Recovery After treatment with Naloxegol in cardiac Surgery Intensive care Trial
    Intérêt du Naloxégol dans la reprise du transit en postopératoire de chirurgie cardiaque
    A.3.2Name or abbreviated title of the trial where available
    TRANSIT
    TRANSIT
    A.4.1Sponsor's protocol code number2019/09
    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 SponsorCMC AMBROISE PARE
    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 supportCMC Ambroise Paré
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCMC Ambroise Pare
    B.5.2Functional name of contact pointclinical trial information
    B.5.3 Address:
    B.5.3.1Street Address25-27 Boulevard Victor Hugo
    B.5.3.2Town/ cityNeuilly sur Seine
    B.5.3.3Post code92200
    B.5.3.4CountryFrance
    B.5.4Telephone number+3310146415079
    B.5.5Fax number+3310146415086
    B.5.6E-mailrecherche@clinique-a-pare.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 MOVENTIG 12.5 mg et 25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderKyowa Kirin Holdings B.V., Bloemlaan 2, Hoofddorp, Pays-Bas
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNaloxegol Oxalate
    D.3.9.3Other descriptive nameNALOXEGOL
    D.3.9.4EV Substance CodeSUB126723
    D.3.10 Strength
    D.3.10.1Concentration unit mCi/mg millicurie(s)/milligram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number12.5 to 25
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ileus after cardiac surgery
    iléus post chirurgie cardiaque
    E.1.1.1Medical condition in easily understood language
    constipation induised by opioïdes after cardiac surgery
    constipation induite par les opioïdes en poste chirurgie cardiaque
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10017501
    E.1.2Term Functional disturbances following cardiac surgery
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10051798
    E.1.2Term Postoperative constipation
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071128
    E.1.2Term Opioid induced constipation
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Prove that the administration of Naloxegol in the perioperative period of cardiac surgery reduces the duration of the postoperative ileus.
    Prouver que l’administration de naloxégol en périopératoire de chirurgie cardiaque permet de réduire la durée de l’iléus postopératoire.
    E.2.2Secondary objectives of the trial
    1- Demonstrate that the administration of Naloxegol decreases digestive complications.
    2- Demonstrate that the administration of Naloxegol decreases respiratory complications (pneumonia, reintubation, length of ventilation)
    3- Rate of infections complications
    4- Verify the effectiveness of analgesia
    5- Compare the length of hospital stay
    6- Compare the duration of ICU stay
    1- Prouver que l’administration de naloxégol diminue les complications digestives
    2- Prouver que l’administration de naloxegol diminue les complications respiratoires
    3- Evaluer le taux de complications infectieuses
    4- Vérification du maintien d’une analgésie normale dans les deux groupes
    5- Comparer les durées totales d’hospitalisation
    6- Comparer les durées de séjour en réanimation et en unité de soin continue (USC)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - > 18 years old,
    - Undergoing cardiac surgery with cardiopulmonary bypass,
    - Having signed a written informed consent form,
    - Affiliation to the social security system
    - De plus de 18 ans
    - Programmés pour une chirurgie cardiaque sous CEC non urgente (moins de 24h)
    - Ayant donné leur consentement écrit de participation
    - Bénéficiant d’un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Allergy or known hypersensitivity to Naloxegol,
    - Pregnant or breastfeeding women
    - Severe hepatic failure, history of cirrhosis
    - Moderate or severe renal failure (GFR<30ml/min)
    - Concomitant treatment with a strong cytochrome P450 3A4 inhibitor
    - History of acute gastro-intestinal obstruction known or suspected
    - Clinically relevant alteration of the blood-brain-barrier
    - Cancer patient with increased risk of gastro-duodunal perforation
    - Disorder that could alter the integrity of the gastrointestinal lining
    - Regular treatment with laxative drugs
    - Concomitant treatment with methadone
    - Patients unabel to take a drug by oral route
    - Patient under protection of the adults (guardianship, curators or safeguard of justice),
    - Patient included or planning to be included in another research protocol relating to medications.
    - Femmes enceintes ou allaitantes
    - Patient sous tutelle, curatelle ou sauvegarde de justice ou incapable de donner un consentement
    - Allergie ou intolérance connue au naloxégol
    - Insuffisance hépatique sévère (classe C de Child-Pugh), antécédent de cirrhose
    - Insuffisance rénale modérée ou sévère (définie par un DFG<30ml/min en MDRD)
    - Antécédent d’occlusion gastro-intestinale aiguë connue ou suspectée
    - Affection susceptible d’altérer l’intégrité de la paroi gastro-intestinale (par exemple, ulcère gastroduodénal sévère, maladie de Crohn, diverticulite active ou récidivante, tumeurs infiltrantes du tractus gastro-intestinal ou métastases péritonéales)
    - Patient atteint d’un cancer et qui présente un risque accru de perforation gastro-duodénale
    - Altération cliniquement importante de la barrière hémato-encéphalique (par exemple : tumeur cérébrale primitive, métastases ou autre pathologie inflammatoire au niveau du SNC, sclérose en plaques active, maladie d’Alzheimer à un stade avancé, etc.)
    - Traitement concomitant par un inhibiteur puissant du CYP3A4 (par exemple, clarithromycine, kétoconazole, itraconazole ou télithromycine ; les inhibiteurs de protéase tels que le ritonavir, l’indinavir ou le saquinavir ; le jus de pamplemousse lorsqu’il est consommé en grande quantité)
    - Traitement concomitant par methadone
    - Patient prenant un traitement laxatif régulièrement
    - Patient qui n’est pas capable d’avaler un comprimé entier avec peu d’eau
    - Patient inclus ou sur le point d’être inclus dans un autre protocole de recherche relatif à des traitements médicamenteux
    E.5 End points
    E.5.1Primary end point(s)
    Time (hour) to transit recovry in postoperative of cardic surgery defined by the number of hour between the first anesthesic induction and the first bowel movement
    Temps (en heures) de reprise du transit en postopératoire d’une chirurgie cardiaque définie par la durée en heure entre la première induction anesthésique et l’émission de la première selle significative
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 days
    5 jours
    E.5.2Secondary end point(s)
    1. rate of digestive complications defined as:
    - intra-abdominal pressure
    - Ogilvie syndrome
    - vomiting
    - mesenteric ischemia
    - need of colonoscopy
    - placement nasogastic tube
    - solid food intolerance at day 2

    2. rate of respiratory complications defined as:
    - duration (hours) of invasive ventilation then non –invasive ventilation
    - Reintubation
    - invasive or not invasive ventilation at day 2
    - pneumonia defined.

    3. rate of infections complications : Sepsis, sternal wound infection

    4. Evaluation of pain with visual analogue scale (VAS) at day 1,2,3 and with post operative opioid consumption
    5. Duration of hospital stay
    6. Duration of ICU stay
    1. Taux de complications digestives basé sur les critères suivants :
    - Pression intra-abdominale
    - Vomissements
    - Syndrome d’Ogilvie
    - Ischémie mésentérique
    - Nécessité d’une coloscopie
    - Mise en place d’une sonde naso-gastrique
    - Intolérance à l’alimentation solide à J2

    2. Taux de complications respiratoires basé sur les critères suivants :
    - Durée (en heures) de ventilation assistée invasive puis non invasive
    - Réitubation
    - Ventilation assistée invasive ou non à J2
    - Pneumopathies

    3. Taux de complications infectieuses : Septicémie, Infection sternale superficielle ou profonde

    4. Evaluation de la douleur par l’EVA (Echelle visuelle analogique) à J1, J2 et J3 et par la consommation totale d’opioïde en équivalent morphinique en mg selon les équivalences communément admises entre les voies orale, sous cutanée et intraveineuse et les différents morphiniques.

    5. Durée en jours d’hospitalisation
    6. Durée en jours de séjour en réanimation et en USC
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days
    30 jours
    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 No
    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 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.8.2.4Number 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
    LVLS
    Dernière visite de la dernière personne participant à l'essai
    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 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.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state300
    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
    aucun
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-01
    P. End of Trial
    P.End of Trial StatusOngoing
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