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    Summary
    EudraCT Number:2006-005335-16
    Sponsor's Protocol Code Number:P051043
    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:2007-01-11
    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 number2006-005335-16
    A.3Full title of the trial
    OMEPRAZOLE 1 - Recherche de dose et Pharmacocinétique de population de l'Oméprazole chez le nouveau-né en traitement du reflux gastro-oesophagien.
    A.3.2Name or abbreviated title of the trial where available
    OMEPRAZOLE 1
    A.4.1Sponsor's protocol code numberP051043
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 MOPRAL
    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.3.1Product nameMOPRAL
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNOméprazole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Le reflux gastro-oesophagien (RGO) chez le Nouveau-Né
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10017924
    E.1.2Term Reflux gastro-oesophagien
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objectif principal
    Evaluer la dose minimale efficace d'oméprazole permettant d'obtenir chez le nouveau-né souffrant d'un reflux gastro-oesophagien documenté par pHmétrie, une efficacité à court terme (72 + ou - 24 heures) sur les données de pHmétrie de contrôle.
    E.2.2Secondary objectives of the trial
    Objectifs secondaires:
    Evaluer la tolérance de l'oméprazole chez les nouveaux nés.
    Evaluer aux doses utilisées l'effet de l'oméprazole sur les symptômes cliniques dans les 120 heures suivant l'initiation du traitement..
    Evaluer aux doses utilisées l'effet de l'oméprazole sur le pH oro-pharyngée en comparant les pH oro-pharyngés avant et sous traitement.
    Etudier la corrélation entre la mesure du pH oropharyngé et les résultats de la pHmétrie
    Réaliser une étude pharmacocinétique de population et pharmacogénétique de l'oméprazole.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1-Nouveaux nés à terme ou prématurés ayant atteint au moins l'âge post-conceptionnel de 35 semaines présentant une pHmétrie pathologique (temps de pH < 4 supérieur ou égal à 5 % du temps d'enregistrement)
    Indication de pHmétrie :
    -Soit systématique : il s'agit des nouveau-nés nés à un terme inférieur à 30 SA et ayant atteint l'âge post conceptionnel de 35 semaines
    -Soit présentant des signes cliniques évocateurs de reflux gastro-oesophagien (malaise, signes respiratoires) et ayant atteint l'âge post conceptionnel de 35 semaines
    2-Recevant une alimentation discontinue par biberons
    3-Consentement écrit des deux parents (des titulaires de l'autorité parentale)
    4-Affilié à un régime de sécurité sociale ou bénéficiant de la CMU
    5-Hospitalisés dans le service de néonatologie de l'Hôpital Robert Debré.
    E.4Principal exclusion criteria
    1-Nouveau-né ayant reçu de l'oméprazole ou un autre inhibiteur de la pompe à proton avant l'inclusion et notamment avant l'arrivée en néonatologie
    2-Nouveau-né présentant des troubles digestifs (diarrhée principalement)
    3-Nouveau-né présentant des perturbations du bilan biologique réalisé pour sa prise en charge :
    -perturbations hématologiques : leucopénie ou thrombopénie inférieures à deux fois la valeur normale pour l'âge
    -transaminases supérieures à deux fois la normale pour lâge
    4-Absence de consentement des titulaires de l'autorité parentale
    E.5 End points
    E.5.1Primary end point(s)
    Le critère de jugement est un critère binaire de type succès ou échec.
    - Le succès est défini par la normalisation de la pHmétrie à 72 +ou- 24 heures (entre 48 et 96 heures) après le début du traitement, définie par un temps de pH acide (< 4) strictement inférieur à 5 % du temps d'enregistrement)
    - L'échec est défini par un temps de pH acide (< 4) supérieur ou égal à 5 % du temps d'enregistrement lors de la pHmétrie réalisée à 72H (entre 48 et 96 heures) après le début du traitement
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Recherche de dose
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    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 months6
    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 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.5Children (2-11years) No
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    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 Decision2007-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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