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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2014-004282-25
    Sponsor's Protocol Code Number:CHUBX2014/10
    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:2015-06-25
    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 number2014-004282-25
    A.3Full title of the trial
    Subcutaneous route and pharmacology of metoclopramide - SOPHA-Méto
    SOus-cutanée et PHArmacologie du Métoclopramide - SOPHA-Méto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Subcutaneous route and pharmacology of metoclopramide - SOPHA-Méto
    SOus-cutanée et PHArmacologie du Métoclopramide - SOPHA-Méto
    A.3.2Name or abbreviated title of the trial where available
    SOPHA-Meto
    SOPHA-Meto
    A.4.1Sponsor's protocol code numberCHUBX2014/10
    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 Bordeaux
    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 Bordeaux
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de BORDEAUX
    B.5.2Functional name of contact pointResponsable of department
    B.5.3 Address:
    B.5.3.1Street Address12 rue Dubernat
    B.5.3.2Town/ cityTalence
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number+33557827758
    B.5.5Fax number+33556794926
    B.5.6E-mailfrederic.perry@chu-bordeaux.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 Primpéran
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis France
    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 nameMetoclopramide
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous 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
    Digestive disorder (Nausea and vomiting) in palliative care and oncology
    Nausées et vomissements chez des patients pris en charge dans un service palliatif ou d'oncologie.
    E.1.1.1Medical condition in easily understood language
    Digestive disorder (Nausea and vomiting) in palliative care and oncology
    Nausées et vomissements chez des patients pris en charge dans un service palliatif ou d'oncologie.
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    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
    Clarify subcutaneous absorption of metoclopramide
    Préciser l’absorption sous-cutanée du métoclopramide.
    E.2.2Secondary objectives of the trial
    Specify the SC absorption of metoclopramide for each dose of the study (10, 20 and 40 mg / d)
    Evolution relationship of the dose-bioavailability for the SC route
    Comparison of plasma dose-concentration metoclopramide by SC and IV through their apparent clearances
    Check local tolerance of the injectable metoclopramide for IV and SC administration
    Compare the clinical effect of metoclopramide in SC and IV route.
    Préciser l’absorption SC du métoclopramide pour chaque dose de l’étude (10, 20 et 40 mg/j)
    Evolution de la relation dose-biodisponibilité pour la voie SC
    Comparaison des relations dose-concentration plasmatique du métoclopramide par voie SC et IV par l’intermédiaire de leurs clairances apparentes ;
    Vérifier la tolérance locale du métoclopramide injectable en administration IV et SC.
    Comparer l’effet clinique du métoclopramide par voie SC et IV
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Man or woman aged at least 18 years
    - Patient hospitalized at the University Hospital of Bordeaux on palliative department
    - Patients with life expectancy estimated by the investigator, is greater than 3 weeks
    - Patients suffering from nausea the day of inclusion with a score greater than or equal to 3/10 on a numerical scale and / or had at least one vomiting within three days prior to inclusion
    - Patient can be infused IV and SC
    - Patient can communicate verbally or in writing
    - Patient has given its written consent
    - Homme ou femme âgé(e) d’au moins 18 ans
    - Patient hospitalisé à l’USP du CHU de Bordeaux
    - Patient dont l’espérance de vie, estimée, par l’investigateur, est supérieure à 3 semaines
    - Patient souffrant de nausée le jour de l’inclusion avec un score supérieur ou égal à 3/10 sur une échelle numérique (EN) allant de 0 à 10 et/ou ayant eu au moins un vomissement dans les trois jours précédant l’inclusion
    - Patient pouvant être perfusé par voie IV et SC
    - Patient pouvant communiquer verbalement ou par écrit
    - Patient ayant donné son consentement par écrit
    E.4Principal exclusion criteria
    - Pregnant or breastfeeding women
    - Current treatment for severe and progressive threatening disease
    - Treatment with oral or injectable metoclopramide within 3 days prior to inclusion
    - Current Treatment with levodopa or dopamine agonists
    - Neuroleptic Processing
    - Presence of clinical signs of encephalopathy (flapping, drowsiness, disorientation)
    - Patient achieved a lesion occlusive syndrome according to the investigator,
    - Patients at risk of gastrointestinal perforation according to the investigator
    - Patient with clinical signs of gastrointestinal bleeding
    - Patient with dyskinesia
    - Patient with an extra-pyramidal syndrome
    - Known or suspected patients with pheochromocytoma
    - History of allergy to metoclopramide
    - History of methemoglobinemia with metoclopramide
    - History deficit NADH-cytochrome b5 reductase-
    - Patient deprived of liberty by judicial or administrative decision
    - Major protected by law
    - Patient exclusion period relative over another protocol.
    - Femme enceinte ou allaitante
    - Traitement en cours pour la maladie grave et évolutive menaçant le pronostic vital
    - Traitement par métoclopramide oral ou injectable dans les 3 jours précédant l’inclusion
    - Traitement en cours par lévodopa ou agonistes dopaminergiques
    - Traitement neuroleptique en cours
    - Présence de signes cliniques d’encéphalopathie (flapping, hypovigilance, désorientation)
    - Patient atteint, selon l’investigateur, d’un syndrome occlusif lésionnel
    - Patient à risque de perforation digestive, selon l’investigateur
    - Patient présentant des signes cliniques d'hémorragie gastro-intestinale
    - Patient présentant des dyskinésies
    - Patient présentant un syndrome extra-pyramidal
    - Patients porteurs, connus ou suspectés, de phéochromocytome
    - Antécédents d’allergie au métoclopramide
    - Antécédents de méthémoglobinémie avec le métoclopramide
    - Antécédents de déficit en NADH-cytochrome-b5 réductase
    - Patient privé de liberté par décision judiciaire ou administrative
    - Majeur protégé par la loi
    - Patient en période d’exclusion relative par rapport à un autre protocole.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the absolute bioavailability of SubCutaneous administration metoclopramide, calculated by the average ratio of plasma concentrations between Subcutaneous and IntraVenous route on all doses of the study (10, 20 and 40 mg / d).
    Le critère de jugement principal de cette étude est la biodisponibilité absolue du métoclopramide en administration SC, calculé par le ratio moyen des concentrations plasmatiques entre la voie SC et la voie IV sur l’ensemble des doses de l’étude (10, 20 et 40 mg/j).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 13
    Jour 13
    E.5.2Secondary end point(s)
    - The absolute bioavailability of metoclopramide subcutaneously at each dose of the study (10, 20 and 40 mg / d) calculated by the ratio of plasma concentrations between SC route and the IV route;
    - Dose-bioavailability of metoclopramide for the SC route;
    - The plasma concentration-dose relationship metoclopramide subcutaneously and intravenously measured through their apparent clearances (CL / F = D / T × 1 / Css), the creatinine clearance in patients is estimated to using the MDRD formula;
    - Cutaneous and subcutaneous inflammatory signs (heat, swelling, pain, redness) at the puncture site;
    - The effectiveness of metoclopramide on nausea and vomiting will be assessed at each dose level and for each route of administration by :
    *An numerical scale ranging from 0 to 10 for nausea;
    *The number of vomiting in the dose level;
    *The use of a setron during dose level.
    - les biodisponibilités absolues du métoclopramide par voie SC à chaque dose de l’étude (10, 20 et 40 mg/j) calculées par le ratio des concentrations plasmatiques entre la voie SC et la voie IV ;
    - la relation dose-biodisponibilité du métoclopramide pour la voie SC ;
    - les relations dose-concentration plasmatique du métoclopramide par voie SC et par voie IV mesurées par l’intermédiaire de leurs clairances apparentes (Cl/F = D/T × 1/Css), la clairance de la créatinine des patients étant estimée à l’aide de la formule MDRD ;
    - les signes inflammatoires cutanés et sous-cutanés (chaleur, tuméfaction, douleur, rougeur) au niveau du site de ponction ;
    - l’efficacité du métoclopramide sur les nausées et vomissements sera appréciée, à chaque palier de dose et pour chaque voie d’administration, par :
    * une échelle numérique allant de 0 à 10 pour la nausée ;
    * le nombre de vomissements au cours du palier de dose ;
    *le recours à un sétron au cours du palier de dose.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 13
    Jour 13
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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
    comparaison entre deux voies d'injections
    comparison between two routes of injection
    E.8.2.4Number of treatment arms in the trial1
    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
    DVDP
    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 months18
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state24
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
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