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    Summary
    EudraCT Number:2015-005704-29
    Sponsor's Protocol Code Number:LUNG-NEPA
    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:2020-12-17
    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 number2015-005704-29
    A.3Full title of the trial
    A standard regimen of dexamethasone in comparison to two dex-sparing regimens in addition to NEPA in preventing CINV in na¿ve NSCLC patients to be treated with cisplatin based chemotherapy: a three-arm, open-label, randomized study
    Regime standard verso due regimi ridotti di desametasone, in associazione a NEPA, per la prevenzione della CINV in pazienti na¿ve con NSCLC in trattamento con chemioterapia a base di cisplatino: studio a tre bracci di trattamento, in aperto e randomizzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A three-arm study comparing a standard regimen of dexamethasone with two dex-sparing regimens in addition to NEPA in preventing chemotherapy-induced nausea and vomiting (CINV) in na¿ve non-small cell lung cancer (NSCLC) patients to be treated with cisplatin based chemotherapy
    Studio a tre bracci di trattamento che confronta un regime standard e due regimi ridotti di desametasone, in associazione a NEPA, per la prevenzione della nausea e del vomito indotti da chemioterapia (CINV) in pazienti na¿ve con tumore del polmone non a piccole cellule (NSCLC) in trattamento con chemioterapia a base di cisplatino
    A.3.2Name or abbreviated title of the trial where available
    Dexamethasone-sparing approach including NEPA against emesis caused by cisplatin
    Riduzione di desametasone in associazione a NEPA contro il vomito causato da cisplatino
    A.4.1Sponsor's protocol code numberLUNG-NEPA
    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 SponsorCONSORZIO ONCOTECH
    B.1.3.4CountryItaly
    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 supportItalfarmaco S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Technology
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressVia San Leonardo - Traversa Migliaro
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.4Telephone number089301545
    B.5.5Fax number0897724155
    B.5.6E-maillunepa@oncotech.org
    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 Akynzeo
    D.2.1.1.2Name of the Marketing Authorisation holderHelsinn Birex Pharmaceuticals Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAkynzeo
    D.3.2Product code NEPA
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNetupitant/palonosetron
    D.3.9.2Current sponsor codeNEPA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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 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 DECADRON - 8 MG/2 ML SOLUZIONE INIETTABILE 3 FIALE DA 2 ML
    D.2.1.1.2Name of the Marketing Authorisation holderFARMACEUTICI CABER S.P.A.
    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.3.1Product nameDecadron
    D.3.2Product code Desametasone
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Intravenous use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESAMETASONE
    D.3.9.2Current sponsor codeDEX
    D.3.9.3Other descriptive nameDexamethasone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number12
    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 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 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
    Chemotherapy-Induced Nausea and Vomiting (CINV) in non-small cell lung cancer (NSCLC) patients receiving a cisplatin-based chemotherapy
    Nausea e vomito indotti da chemioterapia (CINV) in pazienti con tumore del polmone non a piccole cellule (NSCLC), che saranno trattati con chemioterapia a base di cisplatino
    E.1.1.1Medical condition in easily understood language
    Chemotherapy-Induced Nausea and Vomiting in non-small cell lung cancer patients
    Nausea e vomito indotti da chemioterapia in pazienti con tumore del polmone non a piccole cellule
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008443
    E.1.2Term Chemotherapy antiemetic prophylaxsis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10054133
    E.1.2Term Prophylaxis of nausea and vomiting
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008448
    E.1.2Term Chemotherapy induced emesis prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10049091
    E.1.2Term Chemotherapy antiemetic prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10036899
    E.1.2Term Prophylaxis against chemotherapy induced vomiting
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008449
    E.1.2Term Chemotherapy inducted emesis prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the possibility to reduce the total dose of dexamethasone, when administered with NEPA, to prevent chemotherapy-induced nausea and vomiting in NSCLC patients receiving a cisplatin-based chemotherapy
    Valutare la possibilit¿ di ridurre la dose totale di desametasone, quando somministrato in associazione con NEPA, per la prevenzione della CINV in pazienti affetti da tumore del polmone non a piccole cellule sottoposti a chemioterapia a base di cisplatino
    E.2.2Secondary objectives of the trial
    Evaluation of:
    - nausea and vomiting control,
    - patients¿ quality of life
    - patient¿s satisfaction with antiemetic therapy
    - safety profile.
    Cancer-associated weight loss, nutritional status and symptoms assessment.
    Valutazione di:
    - controllo della nausea e del vomito
    - qualit¿ della vita dei pazienti
    - livello di soddisfazione del paziente alla terapia antiemetica
    - profilo di sicurezza
    Valutazione della perdita di peso, dello stato nutrizionale e dei sintomi associati al tumore
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients = 18 years old.
    - Histologically or cytologically confirmed diagnosis of NSCLC
    - Patients na¿ve to cisplatin-containing chemotherapy as well as any prior chemotherapy containing either highly or moderately emetogenic agents (see Appendix 3) given for NSCLC or other malignancy.
    - Patients scheduled to receive their first cycle of cisplatin-based chemotherapy at a dose =70 mg/m2 either alone or in combination with other agents of low or minimal potential of emetogenicity (i.e., pemetrexed, gemcitabine±bevacizumab, vinorelbine) as neo-adjuvant, adjuvant or palliative therapy. Patients with progressive disease on therapy with an EGFR-TKI and scheduled to receive cisplatin-based chemotherapy will be eligible for the study.
    - ECOG Performance Status of 0-1.
    - Body Mass Index =18.5.
    - Written informed consent before study entry.
    - If women of childbearing potential age: reliable contraceptive measures must be used during all the planned course of chemotherapy and up to 30 days after last NEPA administration.
    - Normal hepatic function (=2 times the upper limit of normal for liver transaminases) and renal function (creatinine = 1.5 times the upper limit of normal).
    - Ability and willingness of the patient to complete the diary and study questionnaires.
    - Pazienti con età maggiore o uguale a 18 anni.
    - Diagnosi istologicamente/citologicamente confermata di NSCLC.
    - Pazienti naive per chemioterapia a base di cisplatino nonché per qualsiasi altra precedente chemioterapia con farmaci ad elevato o moderato potere emetizzante (vedasi Appendice 3 del protocollo) somministrati per il trattamento del NSCLC o altri tumori.
    - Pazienti candidati a ricevere il loro primo ciclo di chemioterapia a base di cisplatino, con una dose = 70 mg/m2, sia in monoterapia che in combinazione ad altri agenti a basso o minimo potere emetizzante (ad es. pemetrexed, gemcitabina ± bevacizumab, vinorelbina) con finalità neoadiuvante, adiuvante o palliativa. Pazienti in progressione di malattia in terapia con un EGFR-TKI e candidati a ricevere chemioterapia a base di cisplatino, saranno eleggibili per lo studio.
    - ECOG Performance Status 0-1.
    - Indice di massa corporea (BMI) maggiore o uguale a 18.5.
    - Consenso informato scritto prima dell’ingresso nello studio.
    - In caso di donna in età fertile: uso di adeguati metodi contraccettivi per tutto il periodo pianificato di chemioterapia e fino a 30 giorni dopo l’ultima somministrazione di NEPA.
    - Funzionalità renale ed epatica nella norma (transaminasi = 2 volte il valore massimo; creatinina = 1,5 volte il valore massimo).
    - Capacità e volontà da parte del paziente di compilare il diario e i questionari di studio.
    E.4Principal exclusion criteria
    - Symptomatic brain metastases.
    - Patients scheduled to receive radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5 following the first cycle of chemotherapy.
    - Patients scheduled to receive concurrent - Treatment with investigational medications within 30 days before the study medication.
    - Myocardial infarction within the last 6 months.
    - Documented or known hypersensitivity to 5HT3RA or NK-1RA and excipients.
    - Uncontrolled diabetes mellitus or active infection.
    - Nausea and vomiting in the 24 hours before study treatment.
    - Chronic use of systemic corticosteroids (except for topical and inhaled corticosteroids) or any other agent with anti-emetic potential. Patients receiving dexamethasone on the day before chemotherapy for prevention of the pemetrexed-induced skin rash will be eligible for the study.
    - Patient’s inability to take oral medication.
    - Gastrointestinal obstruction or active peptic ulcer.
    - Pregnancy or breast feeding.
    - Prior malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for at least 5 years (see also inclusion criteria if prior chemotherapy treatment).
    - Psychiatric or CNS disorders interfering with ability to comply with study protocol.
    - Metastasi cerebrali sintomatiche.
    - Pazienti candidati a ricevere radioterapia addominale o pelvica 1 settimana prima del giorno 1 o tra il giorno 1 e il giorno 5 successivi al primo ciclo di chemioterapia.
    - Pazienti candidati a ricevere radioterapia/chemioterapia concomitante per il trattamento del NSCLC.
    - Trattamento con farmaci sperimentali nei 30 giorni antecedenti il trattamento con NEPA.
    - Infarto del miocardio negli ultimi 6 mesi.
    - Nota ipersensibilità ai 5-HT3 antagonisti o agli NK1 antagonisti o agli eccipienti.
    - Diabete mellito non controllato o infezioni attive.
    - Nausea e vomito nella 24 ore precedenti il trattamento.
    - Uso cronico di corticosteroidi sistemici (ad eccezione dei corticosteroidi topici o per inalazione) o qualsiasi altro agente con potenzialità antiemetiche. I pazienti trattati con desametasone il giorno prima della chemioterapia per la prevenzione dell’eruzione cutanea indotta da pemetrexed, saranno candidabili allo studio.
    - Incapacità del paziente di assumere farmaci per via orale.
    - Ostruzione gastrointestinale o ulcera peptica attiva.
    - Gravidanza o allattamento.
    - Precedenti tumori in altri siti ad eccezione di quelli trattati chirurgicamente, come cancri cutanei di natura non melanomatosa, cancri cervicali superficiali , o altri per cui sia stato documentato uno stato di eradicazione da = 5 anni (vedasi anche criteri di inclusione per i trattamenti chemioterapici antecedenti).
    - Disordini psichiatrici o del Sistema Nervoso Centrale (CNS) che possano interferire con la possibilità di aderire alle richieste del protocollo di studio.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients achieving a complete response (CR), defined as no emetic episode and no use of rescue medication, during the overall 5-day study period after the first cycle of chemotherapy
    Valutare il numero di pazienti che ottengono una risposta completa (CR), definita come assenza di episodi di vomito o di impiego di medicazioni antiemetiche, durante i 5 giorni successivi alla somministrazione del primo ciclo di chemioterapia
    E.5.1.1Timepoint(s) of evaluation of this end point
    The overall 5-day study period after the first cycle of chemotherapy
    5 giorni successivi alla somministrazione del primo ciclo di chemioterapia
    E.5.2Secondary end point(s)
    o Complete Response (acute and delayed).
    o Complete control, defined as no emetic episode, no rescue medication, and no more than mild nausea. Severity of nausea will be self-reported by the patient using a verbal scale (none, mild, moderate, and severe).
    o Proportion of patients with no emetic episode.
    o Proportion of patients with no nausea.
    o Impact of nausea and vomiting on patient¿s quality of life as recorded by the Italian version of the FLIE questionnaire, according to subjective assessment by each patient on day 6.
    o Patient global satisfaction with antiemetic therapy, as measured by a VAS on day 6.
    o Safety profile according to NCI-CTCAE version 4.3.
    o Cross-sectional baseline evaluation of weight loss and nutritional intake. Weight loss will be assessed through the BMI adjusted weight loss grading system (WLGS) while nutritional intake will be assessed with and ad hoc question adapted from the Patient Generated-Subjective Global Assessment PG-SGA. Estimation of patient distribution into the five different categories of the WLGS will be also carried out.
    o Cancer-related symptom self-assessment as recorded by the Italian version of the ESAS questionnaire, according to subjective assessment by each patient on day 1 (before chemotherapy initiation) will be performed and its association with WLGS and nutritional intake will be examined.
    o Risposta completa (acuta e ritardata)
    o Controllo completo, definito come assenza di episodi di vomito, nessun impiego di terapia di salvataggio e non pi¿ di nausea di grado lieve. La severit¿ della nausea sar¿ autoriportata dal paziente usando una scala verbale (nessuna, lieve, moderata e severa).
    o Percentuali di pazienti liberi da emesi (nessun episodio emetico).
    o Percentuali di pazienti senza episodi di nausea.
    o Impatto della nausea e del vomito sulla qualit¿ di vita del paziente registrato autonomamente dal paziente al giorno 6 post-chemioterapia, sulla versione italiana del questionario FLIE.
    o Livello di soddisfazione dei pazienti alla terapia antiemetica, misurata tramite una scala visiva analogica (Visual Analogue Scale - VAS) il giorno 6.
    o Profilo di sicurezza in accordo ai Common Terminology Criteria for Adverse Events (NCI-CTCAE) versione 4.3.
    o Valutazione trasversale al basale della perdita di peso e dell¿apporto nutrizionale. La perdita di peso sar¿ valutata attraverso il calcolo del BMI adeguato con il weight loss grading system (WLGS), mentre l¿apporto nutrizionale sar¿ valutato con un questionario ad hoc adattato dal Patient Generated-Subjective Global Assessment (PG-SGA). Sar¿ effettuata anche la valutazione della distribuzione dei pazienti nelle 5 diverse categorie del WLGS.
    o Al giorno 1 (prima dell¿inizio della chemioterapia), sar¿ effettuata da ciascun paziente un¿autovalutazione soggettiva dei sintomi associati al tumore, come riportata nella versione italiana del questionario ESAS, e si esaminer¿ la sua associazione con il WLGS e l¿apporto nutrizionale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    They will be evaluated during the acute (within 24 hours post-chemotherapy), delayed (days 2 thorough 5) and overall (days 1 thorough 5) phases of the first cycle of chemotherapy.
    Impact of nausea and vomiting on patient¿s quality of life and Patient¿s global satisfaction with antiemetic therapy will be assessed on day 6.
    The tolerability of study medication will be evaluated during all the safety study period.
    Saranno valutati durante la fase acuta (entro 24 ore dopo la chemioterapia), nella fase ritardata (giorni dal 2 al 5) e nella fase overall (giorni dal 1 al 5) del primo ciclo di chemioterapia.
    L¿impatto della nausea e del vomito sulla qualit¿ di vita del paziente ed il ivello di soddisfazione del paziente alla terapia antiemetica saranno valutati al giorno 6.
    La tollerabilit¿ del trattamento in studio sar¿ valutata durante tutto il periodo dello studio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    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 trial3
    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 concerned41
    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
    LVLS
    LVLS
    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 months50
    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 months50
    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 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) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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 state219
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 219
    F.4.2.2In the whole clinical trial 219
    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)
    Not applicable
    Non applicabile
    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 Decision2016-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
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