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    Summary
    EudraCT Number:2014-002517-39
    Sponsor's Protocol Code Number:PRODIGE34
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2014-07-31
    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 number2014-002517-39
    A.3Full title of the trial
    Randomised phase III trial evaluating adjuvant chemotherapy after the stage III colon adenocarcinoma resection for patient of 70 year old or more

    ETUDE DE PHASE III RANDOMISEE EVALUANT LA CHIMIOTHERAPIE ADJUVANTE APRES RESECTION D’UN ADENOCARCINOME COLIQUE DE STADE III CHEZ LES PATIENTS DE 70 ANS ET PLUS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomised phase III trial evaluating adjuvant chemotherapy after the stage III colon adenocarcinoma resection for patient of 70 year old or more
    ETUDE DE PHASE III RANDOMISEE EVALUANT LA CHIMIOTHERAPIE ADJUVANTE APRES RESECTION D’UN ADENOCARCINOME COLIQUE DE STADE III CHEZ LES PATIENTS DE 70 ANS ET PLUS
    A.3.2Name or abbreviated title of the trial where available
    PRODIGE 34 - ADAGE
    PRODIGE 34 - ADAGE
    A.4.1Sponsor's protocol code numberPRODIGE34
    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 SponsorFédération Francophone de Cancérologie Digestive (FFCD)
    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 supportFFCD itself
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFédération Francophone de Cancérologie Digestive (FFCD)
    B.5.2Functional name of contact pointCécile GIRAULT
    B.5.3 Address:
    B.5.3.1Street Address7 Boulevard Jeanne d’Arc, BP 87900
    B.5.3.2Town/ cityDijon cedex
    B.5.3.3Post code21079
    B.5.3.4CountryFrance
    B.5.4Telephone number33380608013
    B.5.5Fax number33380381841
    B.5.6E-mailcgirault@u-bourgogne.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 Fluorouracile Ebewe
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUOROURACIL
    D.3.9.3Other descriptive nameFLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    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.IMP: 2
    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 Fluorouracile Ebewe
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ
    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.3.4Pharmaceutical form Solution for infusion
    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 INNFLUOROURACIL
    D.3.9.3Other descriptive nameFLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    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.IMP: 3
    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 Elvorine
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER HOLDING 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.3.4Pharmaceutical form Solution for infusion
    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 INNELVORINE
    D.3.9.3Other descriptive nameCALCIUM LEVOFOLINATE
    D.3.9.4EV Substance CodeSUB06054MIG
    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.IMP: 4
    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 Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE
    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.3.4Pharmaceutical form Film-coated 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 INNCAPECITABINE
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    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.IMP: 5
    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 Eloxatine
    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.3.4Pharmaceutical form Solution for infusion
    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 INNOXALIPLATIN
    D.3.9.1CAS number 61825-94-3
    D.3.9.4EV Substance CodeSUB09490MIG
    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
    Adjuvant treatment in stage III adenocarcinoma of the colon fully resected for patient of 70 years and over
    Traitement adjuvant d'un adénocarcinome colique de stade III totalement réséqué chez les patients de 70 ans et plus
    E.1.1.1Medical condition in easily understood language
    Adjuvant treatment in stage III adenocarcinoma of the colon fully resected for patient of 70 years and over
    Traitement adjuvant d'un adénocarcinome colique de stade III totalement réséqué chez les patients de 70 ans et plus
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    The study population will be dichotomized into two groups (group 1 and group 2) according to the investigator's choice, after a multidisciplinary assessment involving geriatric settings.
    The main objective is to compare recurrence-free survival (RFS) at 3 years for 2 therapeutic strategies in each group of patients of 70 years or more, after resection of the stage III colon cancer.
    Group 1 (fit to receive a bi-chemotherapy): we expect an improvement of 7% of the RFS in the arm with oxaliplatin compared to 5FU or capecitabin arm
    Group 2 (unfit to receive bi-chemotherapy): we expect an improvement of 15% of the RFS in the arm with chemotherapy (5-FU or capecitabin) compared with observation alone arm.
    La population âgée de l’étude sera dichotomisée en deux groupes (groupe 1 et groupe 2) selon le choix de l’investigateur, après une évaluation multidisciplinaire, impliquant des paramètres gériatriques.
    L'objectif principal est de comparer la survie sans récidive (SSR) à 3 ans de 2 stratégies thérapeutiques dans chaque groupe de patients âgés de 70 ans ou plus, après résection d’un cancer du côlon de stade III.
    Groupe 1 (aptes à recevoir une bi-chimiothérapie) : on attend une amélioration de 7% de la SSR dans le bras avec oxaliplatine comparé au bras avec 5FU ou capécitabine.
    Groupe 2 (inaptes à recevoir une bi-chimiothérapie): on attend une amélioration de 15% de la SSR dans le bras avec chimiothérapie (5FU ou capécitabine) comparé au bras avec observation seule.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - Dose intensity
    - Safety (NCI CTC 4.0)
    - Time to recurrence,
    - Overall survival,
    - Time to degradation of autonomy,
    - Time to deterioration of the quality of life.
    Les objectifs secondaires sont:
    - dose intensité,
    - tolérance (NCI CTC 4.0),
    - temps jusqu’à récidive,
    - survie globale,
    - temps jusqu’à dégradation de l’autonomie,
    - temps jusqu’à détérioration de la qualité de vie.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    As part of this study, an ancillary biological study will be realized on the tumor sample (removed ​​at the time of the R0 surgery, before inclusion in this study).
    The objective of this biological study is to search predictive and prognostic factors . These will mainly include:
    - An assessment of the prognostic and predictive value of microsatellite instability and tumor V600E BRAF mutation.
    - An assessment of the prognostic value of tumor PI3K mutations in patients treated with aspirin / acetylsalicylic acid taken daily and continuously.
    Dans le cadre de cette étude, il sera réalisé une étude ancillaire biologique sur le prélèvement tumoral (réséqué au moment de la chirurgie R0, avant inclusion dans cette étude).
    Cette étude biologique a pour objectif de rechercher sur ce prélèvement des facteurs prédictifs et pronostics. Il y aura notamment:

    - une évaluation de la valeur pronostique et prédictive de l’instabilité microsatellitaire et de la mutation tumorale V600E de BRAF.
    - une évaluation de la valeur pronostique des mutations de PI3K tumorale chez les patients traités par aspirine/ acide acétyl-salicylique en prise quotidienne et continue.
    E.3Principal inclusion criteria
    - Age ≥ 70 years
    - Patient considered enough fit to receive chemotherapy according to the multidiciplinary committee
    - IADL and Lee score completed and faxed to the CRGA
    - Stage III colonic adenocarcinoma
    - R0 resection of the primary tumor
    - Adjuvant chemotherapy can start within 12 weeks after surgery
    - No prior chemotherapy for colon cancer
    - Self-administered (patient) geriatric questionnaire completed
    - Team geriatric questionnaire completed
    - Signed informed consent
    - Age ≥ 70 ans
    - Patient jugé apte à recevoir une chimiothérapie par la RCP
    - IADL et sScore de Lee détaillé, faxé au CRGA
    - Adénocarcinome colique de stade III
    - Résection R0 de la tumeur primitive
    - Début de la chimiothérapie adjuvante possible dans les 12 semaines après la chirurgie
    - Absence de chimiothérapie antérieure pour le cancer colique
    - Auto-questionnaire gériatrique « patient » complété
    - Questionnaire gériatrique « équipe » complété
    - Consentement(s) éclairé(s) signé(s).
    E.4Principal exclusion criteria
    - Other progressive malignant tumor (cancer not stabilized for less than 2 years )
    - Rectal cancer located within 15 cm from the anal verge by endoscopy or below the peritoneal reflection during surgery
    - Polymorphonuclear neutrophil count <1500/mm3, platelets <100000/mm3 or hemoglobin <9 g / dL
    - Neuropathy for patients in group 1
    - Any contra-indications for the drugs used in the study
    - Geographical, sociological or psychological conditions that would not permit the patient to complete the medical study follow-up visits
    - Autre tumeur maligne évolutive (cancer non stabilisé depuis moins de 2 ans)
    - Cancer rectal localisé à moins de 15 cm de la marge anale en endoscopie ou bien au-dessous de la réflexion péritonéale à la chirurgie
    - Polynucléaires neutrophiles < 1500/mm3, plaquettes < 100000/mm3 ou hémoglobine < 9 g/dL
    - Neuropathie pour les patients du groupe 1
    - Toute contre-indication aux médicaments utilisés dans l’étude
    - Impossibilité de se soumettre au suivi médical de l’essai pour des raisons géographiques, sociales ou psychiques.
    E.5 End points
    E.5.1Primary end point(s)
    The main objective is to compare recurrence-free survival (RFS) at 3 years for 2 therapeutic strategies in each group of elderly patients, after resection of stage III colon cancer.
    Group 1 (fit to receive a bi-chemotherapy): we expect a 7% improvement in recurrence-free survival in the arm with oxaliplatin compared to 5FU or capecitabin arm.
    Group 2 (unfit to receive bi-chemotherapy): we expect a 15% improvement in recurrence-free survival in the chemotherapy arm compared with observation alone arm.
    L’objectif principal est de comparer la survie sans récidive (SSR) à 3 ans de 2 stratégies thérapeutiques dans chaque groupe de patients âgés, après résection d’un cancer du côlon de stade III.
    Groupe 1 (aptes à recevoir une bi-chimiothérapie) : on attend une amélioration de 7% de la survie sans récidive dans le bras avec oxaliplatine comparé au bras avec 5FU ou capécitabine.
    Groupe 2 (inaptes à recevoir une bi-chimiothérapieCT) : on attend une amélioration de 15% de la survie sans récidive dans le bras avec chimiothérapie comparé au bras avec observation seule.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The recurrence-free survival (RFS) is estimated at 3 years after the last patient is randomised
    La survie sans récidive (SSR) est estimée à 3 ans après que le dernier patient soit randomisé.
    E.5.2Secondary end point(s)
    The secondary objectives are to compare for the two treatment strategies for each group:
    - The dose intensity
    - Safety (NCI CTC 4.0)
    - Time to recurrence
    - Overall survival
    - The time to deterioration of autonomy
    - The time to deterioration in quality of life

    Exploratory analyses: reserach of geriatric prognostic factors for the primary endpoint.
    Les objectifs secondaires : Comparer pour les 2 stratégies de traitement, pour chaque groupe :
    - La dose intensité
    - La tolérance (NCI CTC 4.0)
    - Le temps jusqu’à récidive
    - La survie globale
    - Le temps jusqu’à dégradation de l’autonomie
    - Le temps jusqu’à détérioration de la qualité de vie

    Evaluation exploratoire : rechercher les facteurs pronostiques gériatriques pour le critère de jugement principal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All these endoints will be evaluated at 3 years after the last patient is randomised. Overall survival can be re-evaluated later.
    Tout ces critères seront évalués 3 ans après que le dernier patient soit randomisé. La survie globale pourra être réévaluée plus tard.
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned120
    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 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
    The end of the trial is the last visit of the last subject undergoing the trial.
    La fin de l'étude correspond à la dernière visite du dernier patient selon l'étude.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 776
    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 state776
    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)
    it is not different from the expected normal treatment of that condition
    il n'est pas différent du traitement que le patient aurait hors protocole
    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 Decision2014-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-01
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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