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    Summary
    EudraCT Number:2011-000651-16
    Sponsor's Protocol Code Number:0869-208
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-27
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-000651-16
    A.3Full title of the trial
    A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Patients 1
    Studio di Fase III, Randomizzato, in doppio cieco, controllato verso farmaco attivo di confronto, condotto in condizioni di cieco interne, per valutare efficacia e sicurezza di Aprepitant nella prevenzione di Nausea e Vomito indotti da Chemioterapia (CINV) in pazienti pediatrici
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Aprepitant in Pediatric Patients for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)
    Uno studio con APREPITANT nei pazienti pediatrici per la prevenzione della nausea e del vomito a seguito di chemioterapia.
    A.4.1Sponsor's protocol code number0869-208
    A.5.4Other Identifiers
    Name:MK-0869Number:Aprepitant
    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 SponsorMERCK & CO., INC.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharpe & Dohme Corp.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD Italia S.r.l.
    B.5.2Functional name of contact pointRicerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Vitorchiano, 151
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00189
    B.5.3.4CountryItaly
    B.5.4Telephone number0039 02 21018402
    B.5.5Fax number0039 02 21018629
    B.5.6E-mailpaola.fattore@merck.com
    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 EMEND*1CPS 125MG+2CPS 80MG
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP & DOHME SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Capsule
    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 INNAPREPITANT
    D.3.9.1CAS number 170729-80-3
    D.3.9.2Current sponsor codeMK0869
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 EMEND*1CPS 125MG+2CPS 80MG
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP & DOHME SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Capsule
    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 INNAPREPITANT
    D.3.9.1CAS number 170729-80-3
    D.3.9.2Current sponsor codeMK0869
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 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 nameAprepitant
    D.3.2Product code MK-0869
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNAPREPITANT
    D.3.9.1CAS number 170729-80-3
    D.3.9.2Current sponsor codeMK0869
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number3
    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 RoleComparator
    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 ZOFRAN*IM IV 1F 2ML 4MG
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 injection
    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 INNONDANSETRON
    D.3.9.1CAS number 116002-70-1
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 RoleComparator
    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 ZOFRAN*IM IV 1F 4ML 8MG
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 injection
    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 INNONDANSETRON
    D.3.9.1CAS number 116002-70-1
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for oral suspension
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pediatric Chemotherapy induced nausea and vomiting (CINV)
    Prevenzione di nausea e vomito indotti da chemioterapia(CINV)nei bambini.
    E.1.1.1Medical condition in easily understood language
    Nausea and vomiting due to chemotherapy
    Prevenzione di nausea e vomito indotti da chemioterapia(CINV)nei bambini.
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the three-day oral aprepitant regimen (aprepitant plus ondansetron), to ondansetron alone with respect to the efficacy endpoint of Complete Response (no vomiting and no use of rescue medication) in the 120 hours following initiation of emetogenic chemotherapy in Cycle 1 (overall phase).
    Confrontare il regime di somministrazione per via orale di 3 giorni di aprepitant(aprepitant + ondansetron) verso il solo ondansetron (di seguito denominato regime di controllo)in relazione all’endpoint di efficacia rappresentato da risposta completa (scomparsa del vomito e nessuna assunzione di farmaci di soccorso) nelle 120 ore che seguono l’inizio della chemioterapia emetogena nel ciclo 1 (fase complessiva).
    E.2.2Secondary objectives of the trial
    Efficacy:(1) To compare the three-day oral aprepitant regimen, to the control regimen with respect to the efficacy endpoint of Complete Response in the 0 to 24 hours following the initiation of emetogenic chemotherapy in C1 (acute phase).(2) To compare the three-day oral aprepitant regimen, to the control regimen with respect to the efficacy endpoint of Complete Response in the 25 to 120 hours following the initiation of emetogenic chemotherapy in C1 (delayed phase). (3) To compare the three-day oral aprepitant regimen, to the control regimen with respect to the efficacy endpoint of No Vomiting, regardless of rescue medication use, in the 120 hours following the initiation of emetogenic chemotherapy in C1 (overall phase). Safety:To assess the safety and tolerability of the three-day oral aprepitant regimen in patients who are receiving emetogenic chemotherapy in C1
    1)confrontare il regime di somministrazione per via orale di tre giorni di aprepitant+ondansetron verso il regime di controllo in relazione all’endpoint di efficacia rappresentato da risposta completa da 0 a 24 ore successive all’inizio della chemioterapia emetogena nel ciclo 1 (fase acuta), 2)da 25 a 120 ore successive all’inizio della chemioterapia emetogena nel ciclo 1 (fase ritardata), 3)confrontare il regime aprepitant+ondansetron verso il regime di controllo in relazione all’endpoint di efficacia, rappresentato dall'assenza di episodi di vomito, indipendentemente dall’utilizzo di farmaci di soccorso, nelle 120 ore che seguono l’inizio della chemioterapia emetogena nel ciclo 1 (fase complessiva), 4)valutare la sicurezza e la tollerabilità del regime aprepitant+ondansetron in pazienti, da 0 a 17 anni d’età, sottoposti a chemioterapia emetogena nel ciclo 1.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is 0 (at least 37 weeks gestation and ≥ 3kg) to 17 years of age at time of study entry. 2. Parent/guardian (legally authorized representative) agrees to the patient's participation as indicated by parent/legal guardian signature on the informed consent form. Patients 12 to 17 years of age, or as required by local regulation, assents and has the ability to understand the nature and intent of the study including the ability to comply with study procedures, complete study questionnaires, and is willing to keep scheduled study visits. 3. Patient is scheduled to receive chemotherapeutic agent(s) associated with moderate, high risk or very high risk of emetogenicity for a documented malignancy, or a chemotherapy regimen not previously tolerated due to vomiting. 4. Patient is expected to receive ondansetron as part of their antiemetic regimen. 5. Female patient who has begun menses has a negative urine pregnancy test prior to randomization. A female patient who is of reproductive potential agrees to remain abstinent or use a barrier form of contraception for at least 14 days prior to, throughout, and for at least one month following the last dose of study medication. Women taking oral contraception must agree to add a barrier form of contraception. For countries where abstinence is not considered an acceptable method of birth control, a locally acceptable birth control method must be used. 6. Patient aged >10 years has a Karnofsky score ≥ 60; patient aged ≤ 10 years has a Lansky Play Performance score ≥ 60 (Appendix 6.2). 7. Patient has a predicted life expectancy of ≥ 3 months.
    1)età compresa tra 0 (almeno 37 settimane di gestazione e peso corporeo &gt;= 3kg) e 17 anni al momento dell’inizio dello studio; 2)Consenso scritto dei genitori e/o del rappresentante legale e/o assenso paziente di partecipare allo studio 3)il regime chemioterapico previsto per il/la paziente con una neoplasia documentata deve essere associato a rischio moderato, elevato e molto elevato di emetogenicità, o deve essere un regime precedentemente non tollerato a causa di episodi di vomito 4)il regime antiemetico previsto per il/la paziente deve includere la somministrazione di ondansetron 5)per le pazienti in età fertile deve essere test gravidanza negativo e devono accettare metodo contraccettivo adeguato per almeno 1mese dopo l’ultima dose farmaco sperimentale 6) Il/La paziente di età &gt;10 anni deve avere un punteggio Karnofsky &gt;=60; il/la paziente di età &lt;= 10 anni deve avere un punteggio Lansky Play Performace &gt;=60 7)aspettativa di vita prevista per il/la paziente deve essere di almeno 3 mesi.
    E.4Principal exclusion criteria
    1. Patient has vomited in the 24 hours prior to Treatment Day 1. 2. Patient is allergic to aprepitant, ondansetron, or any other 5-HT3 antagonist. 3. Patient has a symptomatic primary or metastatic CNS malignancy causing nausea and/or vomiting. Patient who is asymptomatic is allowed to participate. 4. Patient has abnormal laboratory values as follows (deviations from these guidelines require discussion with the Merck Clinical Monitor): a. Bone Marrow Function I. Peripheral absolute neutrophil count (ANC) <1000/mm3 II. Platelet count <100,000/ mm3 b. Liver Function I. AST>5.0 x upper limit of normal (ULN) for age II. ALT>5.0 x upper limit of normal (ULN) for age III. Bilirubin > 1.5 x upper limit of normal (ULN) for age c. Renal function I. A serum creatinine > 1.5 x upper limit of normal (ULN) for age 5. Patient has had benzodiazepine or opioid therapy initiated within 48 hours of study drug administration, except for single daily doses of triazolam, temazepam, or midazolam -Continuation of chronic benzodiazepine or opioid therapy is permitted provided it was initiated at least 48 hours prior to study drug administration. 6. Patient has been started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is planned to receive a corticosteroid as part of the chemotherapy regimen.
    1)Il/la paziente ha avuto episodi di vomito nelle 24 ore precedenti il primo giorno di trattamento 2)fa uso di droghe illecite o presenta evidenze di abuso di alcol 3)Per il/la paziente è prevista la somministrazione di una terapia di salvataggio con cellule staminali in concomitanza al regime chemioterapico emetogeno 4)La paziente è in gravidanza o allattamento 5)Il/la paziente è allergico/a ad aprepitant, ondansetron o a qualsiasi altro antagonista della 5-HT3 6)è affetto/a da neoplasia primaria, sintomatica o metastatica dell’SNC, che causa nausea e/o vomito. Il/la paziente asintomatico/a può partecipare allo studio 7)anomalie nei valori dei paramentri di laboratorio indicati nel protocollo 8) L’anamnesi del/della paziente evidenzia una patologia che, a giudizio dello sperimentatore, potrebbe confondere i risultati dello studio o costituire un rischio ingiustificato nella somministrazione del farmaco sperimentale 9)Il/la paziente è affetto/a da un’infezione attiva (ad es. polmonite) o da una patologia non controllata 10)paziente sottoposto/a a una terapia a base di benzodiazepine o di oppioidi, iniziata entro 48 ore dalla somministrazione del farmaco sperimentale, fatta eccezione per singole dosi giornaliere di triazolam, temazepam o midazolam.Il proseguimento della terapia cronica a base di benzodiazepine o di oppioidi è consentito a condizione che tale terapia sia iniziata almeno 48 ore prima della somministrazione del farmaco sperimentale 11)paziente sottoposto/a a una terapia corticosteroidea sistemica entro 72 ore prima della somministrazione del farmaco sperimentale, o è prevista la somministrazione di un corticosteroide nell’ambito del regime chemioterapico.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the proportion of patients with Complete Response (No Vomiting and no use of rescue medication) in the 120 hours following initiation of emetogenic chemotherapy.
    L'endpoint primario di efficacia sarà dato dalla proporzione di pazienti con risposta completa (assenza di vomito e nessun uso di farmaci di salvataggio) nelle 120 ore dopo l'inizio
    della chemioterapia emetogena.
    E.5.1.1Timepoint(s) of evaluation of this end point
    120 hours following initiation of emetogenic chemotherapy
    120 ore dopo l'inizio della chemioterapia emetogena
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints will be (1) the proportion of patients with Complete Response in the 0 to 24 hours following initiation of emetogenic chemotherapy; (2) the proportion of patients with Complete Response in the 25 to 120 hours following initiation of emetogenic chemotherapy; and (3) the proportion of patients with No Vomiting, irrespective of use of rescue medication, in the 120 hours following initiation of emetogenic chemotherapy.
    Gli endpoint secondari saranno 1)la percentuale di pazienti con risposta completa da 0 a 24
    ore dopo l'inizio della chemioterapia emetogena 2)la percentuale di pazienti con risposta
    completa da 25 a 120 ore dopo l'inizio della chemioterapia emetogena 3) la percentuale di
    pazienti con assenza di vomito, indipendentemente dall'uso di farmaci di salvataggio, nelle
    120 ore dopo l'inizio della chemioterapia emetogena.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The proportions of patients with Complete Response and No Vomiting will be summarized at 3 time periods; 0 to 24 (acute), 25 to 120 (delayed), and 0 to 120 (overall) hours post initiation of emetogenic chemotherapy, with 0 to 120 hours the primary time point.
    Il numero di pazienti con risposta completa e/o assenza di vomito verranno suddivisi in 3 periodi di tempo rispetto all'inizio delle chemio terapia:
    1)da 0 a 24 ore (fase acuta);
    2)da 25 a 120 (fase ritardata);
    3)da 0 a 120 (fase complessiva)
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Canada
    Chile
    Colombia
    Croatia
    Dominican Republic
    Ecuador
    Guatemala
    Israel
    Korea, Democratic People's Republic of
    Korea, Republic of
    Mexico
    Panama
    Peru
    Russian Federation
    Turkey
    United States
    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
    15 Aug. 2013
    15 Agosto 2013
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months23
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months23
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 300
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 22
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 53
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 150
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 75
    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 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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 300
    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)
    xxxx
    i pazienti proseguiranno il regime di trattamento antiemetico come da pratica clinica sulla base del giudizio del medico responsabile
    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 Decision2011-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-16
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