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    Summary
    EudraCT Number:2009-012797-12
    Sponsor's Protocol Code Number:ACCORD 20/0904 - Prodige 17
    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:2010-07-09
    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 number2009-012797-12
    A.3Full title of the trial
    Essai de phase II randomisé multicentrique évaluant l’efficacité d’une chimiothérapie seule ou combinée à l’AMG 102 ou au panitumumab en traitement de première ligne chez des patients atteints d’adénocarcinome œsogastrique localement avancé (non résécable) ou métastatique.
    A.3.2Name or abbreviated title of the trial where available
    MEGA
    A.4.1Sponsor's protocol code numberACCORD 20/0904 - Prodige 17
    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 SponsorFédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC)
    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 Vectibix
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Information not present in EudraCT
    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 INNPANITUMUMAB
    D.3.9.1CAS number 339177-26-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 Yes
    D.3.11.13.1Other medicinal product typeAnticorps monoclonal IgG2 humain, produit à partir d’une lignée cellulaire de mammifère (CHO) par la technique de l’ADN recombinant.
    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 No
    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 nameAMG 102
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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 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 Yes
    D.3.11.13.1Other medicinal product typeAnticorps monoclonal de type IgG2 humain.
    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 ELOXATINE
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-SYNTHELABO 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 Information not present in EudraCT
    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 61825943
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 ELVORINE
    D.2.1.1.2Name of the Marketing Authorisation holderWYETH PHARMACEUTICALS 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 Cutaneous solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCALCIUM FOLINATE
    D.3.9.1CAS number 1492-18-8
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Fluorouracile
    D.2.1.1.2Name of the Marketing Authorisation holderDAKOTA PHARM
    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 Information not present in EudraCT
    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.3.9.1CAS number 51-21-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Adénocarcinome œsogastrique localement avancé (non résécable) ou métastatique
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer le taux de survie sans progression (SSP) à 4 mois
    E.2.2Secondary objectives of the trial
    • Evaluer la survie sans progression (SSP)
    • Evaluer la survie globale (SG)
    • Evaluer le temps jusqu’à progression (TTP)
    • Evaluer le taux de réponse objective tumorale (RO) (= réponses complètes [RC] et partielles [RP]) selon les critères RECIST V1.1)
    • Evaluer la durée de RO
    • Evaluer le taux de contrôle tumoral (RC + RP + maladie stable [ST])
    • Evaluer la tolérance du traitement (critères NCI CTC AE V4, sauf toxicité neurologique périphérique (échelle de Lévi) et cutanéo-unguéale (critères NCI CTC AE V4)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Identifier des marqueurs pronostiques et prédictifs potentiels de l’effet des traitements, notamment par :

    - Etudes sur échantillons tumoraux en FISH/CISH et biologie moléculaire,
    - Etude pharmacogénétique sur échantillons sanguins,
    - Etude des des cellules tumorales circulantes (CTC) sur échantillons sanguins avant et après début du traitement,
    - Etude des des cellules immunitaires circulantes (CIC) sur échantillons sanguins avant et après début du traitement.

    Le but est d’améliorer les connaissances physiopathologiques sur les cancers oesogastriques localement avancés et métastatiques ainsi que d’identifier des biomarqueurs pronostiques pour cette maladie et des biomarqueurs prédictifs de l’efficacité des traitements à l’étude.
    E.3Principal inclusion criteria
    1) Adénocarcinome de l’estomac, de l’œsophage ou du cardia histologiquement prouvé (avec cellules en bague à chaton ou non ; forme intestinale ou diffuse ou mixte),
    2) Statut HER2 (immunohistochimie 3+ et /ou hybridation in situ +) connu, positif
    3) Maladie localement avancée (non résécable) ou métastatique
    4) Maladie mesurable (au moins une lésion) selon les critères RECIST V1.1 (en dehors d’un champ d’irradiation antérieur)
    5) Absence de chimiothérapie palliative antérieure. Une chimiothérapie néo-adjuvante ou adjuvante est autorisée y compris avec une biothérapie (sauf anti-EGFR ou anti-c-Met/HGF) si elle est terminée depuis au 12 mois
    6) Radiothérapie antérieure autorisée si terminée depuis au moins 14 jours avant la randomisation et si présence d’au moins une cible mesurable en dehors du champ d’irradiation
    7) Absence de chirurgie majeure ≤ 28 jours ou mineure ≤ 14 jours avant la randomisation (sauf mise en place d’un cathéter veineux ou chambre implantable)
    8) Sites de la maladie évalués dans les 28 jours précédant la randomisation par scanner thoraco-abdomino-pelvien (ou imagerie par résonance magnétique abdomino-pelvienne plus radiographie thoracique)
    9) Age ≥ 18 ans
    10) Statut de performance ECOG : 0 ou 1
    11) Espérance de vie attendue ≥ 3 mois
    12) Hémoglobine ≥ 9 g/dl (si nécessaire, transfusion autorisée), polynucléaires neutrophiles ≥ 1,5.10^9/l, plaquettes ≥ 100.10^9/l
    13) Transaminases ≤ 2,5 fois la limite supérieure de la normale (LSN) (si métastases hépatiques, ≤ 5 LSN), phosphatases alcalines ≤ 2,5 LSN (si métastases hépatiques, ≤ 5 LSN), bilirubinémie totale ≤ 1,5 LSN
    14) Clairance de la créatinine (calculée ou mesurée) ≥ 50 ml/min, créatininémie ≤ 1,5 N
    15) Taux de prothrombine supérieur ou égal à 60%, INR < 1,5 (sauf si traitement anticoagulant)
    16) Magnésémie et calcémie ≥ limite inférieure de la normale
    17) Test de grossesse négatif pour les femmes en période d’activité génitale
    18) Information du patient et signature du consentement éclairé
    19) Affiliation à un régime de sécurité sociale
    20) Echantillon tumoral (tumeur primitive ou métastase) disponible
    E.4Principal exclusion criteria
    1) Métastases méningées ou cérébrales connues
    2) Contre-indication spécifique ou allergie ou hypersensibilité connue à l’un des traitements
    3) Traitement antérieur par oxaliplatine, inhibiteur d’EGFR ou inhibiteur de HGF/c-Met
    4) Patient déjà inclus dans un autre essai thérapeutique avec une molécule expérimentale
    5) Présence d’oedèmes périphériques > grade 2
    6) Protéinurie > 1 g/24h (dosage quantitatif requis si protéinurie à la bandelette > 2 +)
    7) Maladie cardio-vasculaire cliniquement significative (dont angor instable, insuffisance cardiaque congestive sévère symptomatique, arythmie cardiaque sévère non contrôlée) dans les 12 mois précédant la randomisation
    8) Thrombose ou évènement vasculaire ischémique au cours des 12 derniers mois (dont thrombose veineuse profonde, embolie pulmonaire, accident vasculaire cérébral ischémique transitoire ou constitué (infarctus cérébral), infarctus du myocarde)
    9) Antécédents ou signes de pneumopathie interstitielle ou de fibrose pulmonaire
    10) Neuropathie périphérique > grade 1
    11) Hémorragie digestive haute cliniquement significative (transfusion ou geste d’hémostase) ≤ 30 jours avant la randomisation
    12) Maladie inflammatoire évolutive de l'intestin ou autre maladie intestinale responsable d'une diarrhée chronique (≥ grade 2)
    13) Toute maladie concomitante non contrôlée (ex. diabète non contrôlé) ou antécédent médical (ex. transplantation d’organe) qui, selon l'avis de l'investigateur, pourrait interférer avec l'interprétation des résultats de l'étude
    14) Toute comorbidité ou situation qui, selon l'avis de l'investigateur, pourrait accroître le risque de toxicité (ex. déficit en dihydropyrimidine déshydrogénase)
    15) Infection par le virus de l'immunodéficience humaine (VIH) ou le virus de l'hépatite B (infection chronique ou active) ou C
    16) Plaie sévère et/ou non cicatrisée
    17) Toute infection active nécessitant un traitement systémique, ou toute infection non contrôlée dans les 14 jours précédant la randomisation
    18) Autre cancer concomitant ou passé (excepté : cancer in situ du col utérin, ou cancer cutané non-mélanome, traité à visée curative), sauf si considéré en rémission complète depuis au moins 5 ans avant la randomisation
    19) Femmes enceintes, susceptibles de l’être (ou prévoyant de l’être jusqu’à 6 mois après la fin du traitement), ou en cours d'allaitement
    20) Hommes ou femmes en âge de procréer ne consentant pas à utiliser une méthode de contraception d’efficacité élevée (selon standards institutionnels en vigueur) ou à une abstinence pendant le déroulement de l'étude et pendant 6 mois après la dernière administration des médicaments de l'étude
    21) Personne privée de liberté ou sous sauvegarde de justice, tutelle ou curatelle
    22) 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)
    Taux de survie sans progression (SSP) à 4 mois.

    La RO sera évaluée par l'investigateur selon les critères RECIST v1.1 2009 modifiés toutes les 8 (± 1) semaines jusqu'à progression de la maladie. Les patients avec des symptômes évocateurs d'une progression de la maladie devront être évalués au plan tumoral au moment de la survenue des symptômes.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned30
    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 years7
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state165
    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 Decision2010-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-06
    P. End of Trial
    P.End of Trial StatusOngoing
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