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    Summary
    EudraCT Number:2010-018560-16
    Sponsor's Protocol Code Number:P090903
    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:2010-04-26
    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 number2010-018560-16
    A.3Full title of the trial
    Ralentissement sévère de la croissance staturale chez les enfants avec anorexie mentale. Essai thérapeutique par l'hormone de croissance.
    A.3.2Name or abbreviated title of the trial where available
    OREX
    A.4.1Sponsor's protocol code numberP090903
    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 Norditropine® simplexx®
    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 nameNorditropine® simplexx®
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsomatotropine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anorexie mentale
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10002649
    E.1.2Term Anorexie mentale
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation de l'efficacité d'un traitement par hormone de croissance sur la vitesse de croissance staturale chez des enfants pré pubères avec anorexie mentale et freination importante de la vitesse de croissance.
    E.2.2Secondary objectives of the trial
    Analyser l'effet du traitement par hormone de croissance sur le métabolisme osseux et phosphocalcique, sur l'évolution psychique et nutritionnelle ainsi que sur la tolérance à ce traitement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Examen médical préalable.
    - Sujets des 2 sexes âgés de 8 à 16 ans et 11 mois, présentant une anorexie mentale clinique et/ou en référence aux critères diagnostiques du DSM-IV (1) avant ou en début de puberté (stade 1 ou 2 de Tanner) et présentant un ralentissement prolongé de la vitesse de croissance pendant au moins 18 mois (VC <= à 2 cm/an), avec un age osseux <= 12 ans chez la fille et 14 ans chez le garçon.
    - Affection diagnostiquée au moins 1 an avant l'étude
    - Vitesse de croissance staturale documentée pendant au moins 18 mois avant l'inclusion
    - Comme pour tout enfant présentant un ralentissement sévère de la vitesse de croissance, une évaluation de la sécrétion de GH devra être réalisée avant l'inclusion (dans le cadre du soin) dans l'essai, qui n'est pas conditionné par la valeur du pic de GH : une valeur de GH < 20 miu/L devra conduire à la réalisation d'une IRM cérébrale (dans le cadre du soin) qui devra être normale (région hypothalamo-hypophysaire normale et absence de pathologie tumorale) pour permettre l'inclusion du patient.
    - Tolérance au glucose normale
    - Condition métabolique stable avec reprise pondérale d'au moins 10% du poids du corps depuis le moment où l'indice de masse corporelle était le plus bas en relation avec la survenue de l'affection et ionogramme sanguin normal (pas d'hypokaliémie).
    - Sujets dont les titulaires de l'autorité parentale ont signé un consentement
    - Sujets dont les titulaires de l'autorité parentale sont affiliés à un régime de sécurité sociale ou CMU* (CMU : couverture médicale universelle) .
    E.4Principal exclusion criteria
    - Sujets en milieu de puberté (stade 3 ou 4 de Tanner) ou ayant déjà présenté une ménarche.
    - Sujets présentant une anomalie chromosomique ou autre pathologie chronique associée nécessitant un traitement au long cours.
    - Intolérance au glucose ou diabète.
    - Impossibilité pour le patient ou l'équipe médicale d'assurer le déroulement et le suivi dans le cadre du protocole.
    - Participation à un autre essai.
    - Bradycardie <50/min.
    - Enfant dont les titulaires de l'autorité parentale ne sont pas bénéficiaires d'un régime de sécurité sociale
    - Contre indication à la Somatropine
    E.5 End points
    E.5.1Primary end point(s)
    Critère de jugement principal

    Pour répondre à l'objectif principal, le critère de jugement principal sera la vitesse de croissance 1 an après le début de l'essai en cm/1an et score de déviation standard. La vitesse de croissance durant la première année de l'étude sera comparée entre le groupe avec hGH et le groupe placebo.

    Critères de jugement secondaires

    - Les données de la composition corporelle obtenues par absorptiométrie biphotonique concerneront le contenu minéral osseux, la masse maigre et la masse grasse, ainsi que leurs rapports. Les mesures seront effectuées au niveau du corps entier, ainsi qu'au niveau du rachis lombaire (contenu minéral osseux). Ces valeurs seront décrites en valeurs absolues et en SDS. Elles seront comparées entre le groupe avec hGH et le groupe placebo. De plus, l'évolution des données de la composition corporelle sur 1 an pourront aussi être comparée avec ceux d'une population d'enfants en bonne santé suivie longitudinalement sur 1 an que nous avons publié (57)*.

    - les données biologiques du métabolisme phosphocalcique (phosphatases alcalines osseuses, CrossLaps) et des facteurs de croissance (IGF-I, IGFBP-3) seront exprimés en Z score par rapport à des valeurs normales de références établies en France de manière transversale chez le sujet sain en fonction de l'âge osseux, du sexe, du stade pubertaire (58)*.

    - L'état psychique (Schedule for Affective Disorders and Schizophrenia for School-Age Children, Kiddie-SADS present and life time version (K-SADS-PL) (50, 51) et nutritionnel (Eating Attitute Test for Children (EAT-Ch ) (52) de chaque patient sera évalué avant, pendant et à la fin de l'étude ainsi que l'évolution générale de la maladie (Questionnaire de Morgan et Russell (54) et la Clinical Global Impression Scale (56)), la dépression (54) et l'estime de soi (55)*.

    * cf références bibliographiques du protocole.
    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 No
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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 state20
    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 Decision2010-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-05
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