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    Summary
    EudraCT Number:2018-004447-23
    Sponsor's Protocol Code Number:RVT1601-CC-04
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-10
    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 number2018-004447-23
    A.3Full title of the trial
    Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial
    Studio randomizzato, in doppio cieco, controllato con placebo, a dose variabile finalizzato a valutare l’efficacia e la sicurezza di RVT-1601 per via inalatoria nel trattamento della tosse persistente nei pazienti con fibrosi polmonare idiopatica (FPI): Sperimentazione SCENIC
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)
    Studio sulll’efficacia e la sicurezza di RVT-1601 per via inalatoria nel trattamento della tosse persistente nei pazienti con fibrosi polmonare idiopatica (FPI)
    A.3.2Name or abbreviated title of the trial where available
    SCENIC Trial
    Sperimentazione SCENIC
    A.4.1Sponsor's protocol code numberRVT1601-CC-04
    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 SponsorRespivant Sciences, GmbH
    B.1.3.4CountrySwitzerland
    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 supportRespivant Sciences GmbH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRespivant Sciences, Inc.
    B.5.2Functional name of contact pointAhmet Tutuncu
    B.5.3 Address:
    B.5.3.1Street Address11455 El Camino Real, Suite 460
    B.5.3.2Town/ citySan Diego, California
    B.5.3.3Post code92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018584361600
    B.5.5Fax number000000
    B.5.6E-mailatutuncu@respivant.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 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 namecromolyn sodio (cromoglicato disodico, DSCG)
    D.3.2Product code [RVT-1601 (in precedenza PA101B)]
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcromoglicato disodico
    D.3.9.1CAS number 15826-37-6
    D.3.9.2Current sponsor codeRVT-1601 (in precedenza PA101B)
    D.3.9.3Other descriptive nameSODIUM CROMOGLICATE
    D.3.9.4EV Substance CodeSUB12286MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number7500
    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 Yes
    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 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 namecromolyn sodio (cromoglicato disodico, DSCG)
    D.3.2Product code [RVT-1601 (in precedenza PA101B)]
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcromoglicato disodico
    D.3.9.1CAS number 15826-37-6
    D.3.9.2Current sponsor codeRVT-1601 (in precedenza PA101B)
    D.3.9.3Other descriptive nameSODIUM CROMOGLICATE
    D.3.9.4EV Substance CodeSUB12286MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number30
    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 Yes
    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 namecromolyn sodio (cromoglicato disodico, DSCG)
    D.3.2Product code [RVT-1601 (in precedenza PA101B)]
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcromoglicato disodico
    D.3.9.1CAS number 15826-37-6
    D.3.9.2Current sponsor codeRVT-1601 (in precedenza PA101B)
    D.3.9.3Other descriptive nameSODIUM CROMOGLICATE
    D.3.9.4EV Substance CodeSUB12286MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number60
    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 Yes
    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 placeboNebuliser solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Persistent cough in Idiopathic Pulmonary Fibrosis (IPF)
    tosse persistente associata alla fibrosi polmonare idiopatica (FPI)
    E.1.1.1Medical condition in easily understood language
    Cough in IPF is often a debilitating symptom that adversely affects quality of life (QoL) and is usually refractory to medical therapy.
    La tosse associata a IPF è spesso un sintomo debilitante che influisce negativamente sulla qualità della vita (QoL) e di solito è refrattaria alla terapia medica.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10070801
    E.1.2Term Persistent cough
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of inhaled RVT-1601 in comparison with placebo following 12 weeks of treatment
    Valutare l’efficacia di RVT-1601 per inalazione rispetto al placebo dopo 12 settimane di trattamento
    E.2.2Secondary objectives of the trial
    • To select the optimal dose of RVT-1601
    • To assess the pharmacokinetic (PK) profile of RVT-1601
    • To assess biomarker response to RVT-1601
    • To assess the impact of RVT-1601 on IPF disease
    • To assess the safety of RVT-1601
    • Selezionare la dose ottimale di RVT-1601
    • Valutare il profilo farmacocinetico (PK) di RVT-1601
    • Valutare la risposta dei biomarcatori a RVT-1601
    • Valutare l’impatto di RVT-1601 sull’IPF
    • Valutare la sicurezza di RVT-1601
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: PK analysis

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: analisi farmacocinetica
    E.3Principal inclusion criteria
    1. Male or female subjects age 40 through 89 years, inclusive
    2. Confirmed diagnosis of IPF with clinical features consistent with the current clinical practice guidelines for IPF
    3. Presence of persistent cough for at least 8 weeks that is primarily due to IPF and not responsive to antitussive therapy
    4. Daytime cough severity score of =40 mm on a 100-mm VAS at the Screening Visit
    5. 24-hour average cough count of at least 10 coughs per hour using an objective cough-count monitor during Screening
    6. Forced Vital Capacity (FVC) > 45% predicted value within 4 weeks of the Screening Visit
    7. Life expectancy of at least 12 months
    8. Willing and able to follow the study required visits and assessments
    9. Willing and able to use the cough monitor for 24-hour periods at select study visits
    10. Willing and able to provide written informed consent prior to studyrelated procedures
    1. Soggetti di sesso maschile o femminile di età compresa tra 40 e 89 anni compresi
    2. Diagnosi confermata di IPF con caratteristiche cliniche coerenti con le attuali linee guida sulla pratica clinica per l’IPF
    3. Presenza di tosse persistente da almeno 8 settimane causata principalmente da IPF e non rispondente alla terapia antitosse
    4. Punteggio di gravità della tosse diurna =40 mm su una scala VAS di 100 mm alla visita di screening
    5. Conteggio della media dei colpi di tosse nell’arco di 24 ore pari ad almeno 10 colpi di tosse all’ora mediante l’uso di un dispositivo di monitoraggio oggettivo durante lo screening
    6. Capacità vitale forzata (CVF) >45% del valore previsto entro 4 settimane dalla visita di screening
    7. Aspettativa di vita di almeno 12 mesi
    8. Disponibilità e capacità di rispettare le visite e le valutazioni previste dallo studio
    9. Disponibilità e capacità di utilizzare il dispositivo di monitoraggio della tosse per periodi di 24 ore in occasione di determinate visite dello st udio
    10. Disponibilità e capacità di fornire il consenso informato scritto prima delle procedure correlate allo studio
    E.4Principal exclusion criteria
    1. Current or recent history of clinically significant medical condition, laboratory abnormality, or illness that could place the subject at risk or compromise the quality of the study data as determined by the investigator
    2. Significant coronary artery disease (i.e., myocardial infarction within 6 months or unstable angina within 1 month of the Screening Visit)
    3. An upper or lower respiratory tract infection within 4 weeks of the Screening Visit
    4. Acute exacerbation of IPF within 6 months of the Screening Visit (Collard et al., 2016)
    5. Lung transplantation expected within 12 months
    6. Requiring supplemental O2 > 4 litres/min to maintain peripherial arterial O2 saturation (SpO2) > 88% at rest
    7. History of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 2 years. This does not include minor surgical procedures for localized cancer (e.g., basal cell carcinoma, prostate carcinoma or cervical carcinoma in situ)
    8. Current smoker (i.e., use of tobacco products within the last 3 months)
    9. Current or recent history of drug or alcohol abuse within 12 months of the Screning Visit
    10. Participation in any other investigational drug study within 4 weeks of the Screening Visit or within 5 times the elimination half life of an investigational drug
    11. Use of the following drugs for cough management within 4 weeks of the Screening Visit: prednisone, opiates, baclofen, gabapentin, pregabalin, thalidomide, amitriptyline, inhaled corticosteroids, or inhaled bronchodilators
    12. Use of ACE inhibitors or cromolyn sodium within 4 weeks of the Screening Visit
    13. Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control during the study (e.g., abstinence, combination barrier and spermicide, hormonal, or male partner sterilization)
    14. History of hypersensitivity or intolerance to cromolyn sodium
    1. Anamnesi attuale o recente di condizioni mediche clinicamente significative, anomalie di laboratorio o malattie che potrebbero mettere a rischio il soggetto o compromettere la qualità dei dati dello studio secondo quanto stabilito dallo sperimentatore
    2. Coronaropatia significativa (ovvero, infarto miocardico entro 6 mesi o angina instabile entro 1 mese dalla visita di screening)
    3. Infezione delle vie respiratorie superiori o inferiori entro 4 settimane dalla visita di screening
    4. Esacerbazione acuta dell’IPF entro 6 mesi dalla visita di screening (Collard et al., 2016)
    5. Trapianto di polmone previsto entro 12 mesi
    6. Necessità di un supplemento di O2 >4 litri/min per mantenere la saturazione arteriosa periferica di O2 (SpO2) >88% a riposo
    7. Anamnesi di neoplasia con probabile esito di invalidità significativa o probabile necessità di intervento medico o chirurgico significativo nei 2 anni successivi. Sono esclusi gli interventi chirurgici minori per cancro localizzato (ad es. carcinoma basocellulare, carcinoma prostatico o carcinoma cervicale in situ)
    8. Tabagismo (ovvero, consumo di prodotti del tabacco negli ultimi 3 mesi)
    9. Anamnesi attuale o recente di abuso di sostanze stupefacenti o alcol entro 12 mesi dalla visita di screening
    10. Partecipazione a qualsiasi altro studio con farmaci sperimentali entro 4 settimane dalla visita di screening o 5 volte l'emivita di eliminazione del farmaco in studio
    11. Uso dei seguenti farmaci per la gestione della tosse entro 4 settimane dalla visita di screening: prednisone, oppiacei, baclofene, gabapentin, pregabalin, talidomide, amitriptilina, corticosteroidi per inalazione o broncodilatatori per inalazione
    12. Uso di ACE inibitori o cromolyn sodio entro 4 settimane dalla visita di screening
    13. Donne in gravidanza o in allattamento oppure in età fertile e non disposte ad adottare metodi anticoncezionali accettabili durante lo studio (ad es. astinenza, combinazione di barriera e spermicida, contraccezione ormonale, sterilizzazione del compagno)
    14. Anamnesi di ipersensibilità o intolleranza al cromolyn sodio
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    Primary endpoint:
    • Change from baseline at the end of treatment in 24-hour average cough count
    Efficacia:
    Endpoint primario:
    • Variazione dal basale a fine trattamento nel conteggio medio dei colpi di tosse nell’arco di 24 ore
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12.
    Settimana 12
    E.5.2Secondary end point(s)
    • Change from baseline at the end of treatment in cough severity as measured by VAS
    • Change from baseline at the end of treatment in cough-specific QoL as measured by LCQ
    • Proportion of responders with a minimum of 20% decrease from baseline at the end of treatment in 24-hour average cough count
    • Change from baseline at the end of treatment in daytime average cough count
    • Change from baseline at the end of treatment in nighttime average cough count
    • Change from baseline at the end of treatment in ILD-specific QoL as measured by K-BILD
    • Change from baseline at the end of treatment in respiratory-related QoL as measured by SGRQ
    • Change from baseline at the end of treatment in dyspnea score as measured by SOBQ
    • Change from baseline at the end of treatment in 6MWT
    • Change from baseline at the end of treatment in FVC
    • Proportion of subjects with no decline (i.e., < 5% decline), 5% - 10% decline, and > 10% decline in FVC % predicted at the end of treatment
    • Change from baseline at the end of treatment in airway and lung volumes as measured by FRI
    • Change from baseline at the end of treatment in average daily oxygen use
    • Change from baseline at the end of treatment in exploratory biomarkers
    • Variazione dal basale a fine trattamento nella gravità della tosse misurata su scala VAS
    • Variazione dal basale a fine trattamento nella QoL specifica per la tosse misurata mediante questionario LCQ
    • Percentuale di soggetti rispondenti con una riduzione minima del 20% dal basale a fine trattamento nel conteggio medio dei colpi di tosse nell’arco di 24 ore
    • Variazione dal basale a fine trattamento nel conteggio medio diurno dei colpi di tosse
    • Variazione dal basale a fine trattamento nel conteggio medio notturno dei colpi di tosse
    • Variazione dal basale a fine trattamento nella QoL specifica per l’ILD misurata mediante questionario K-BILD
    • Variazione dal basale a fine trattamento nella QoL relativa alla respirazione misurata mediante questionario SGRQ
    • Variazione dal basale a fine trattamento nel punteggio della dispnea misurato mediante questionario SOBQ
    • Variazione dal basale a fine trattamento nel test 6MWT
    • Variazione dal basale a fine trattamento nella CVF
    • Percentuale di soggetti senza declino (ovvero, declino <5%), declino del 5%-10% e declino >10% nella CVF% prevista a fine trattamento
    • Variazione dal basale a fine trattamento nei volumi delle vie aeree e dei polmoni secondo la misurazione FRI
    • Variazione dal basale a fine trattamento nell’uso medio diurno di ossigeno
    • Variazione dal basale a fine trattamento nei biomarcatori esplorativi
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12.
    Settimana 12
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    controllato a placebo
    Placebo-Controlled
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Canada
    Czechia
    Germany
    Italy
    Netherlands
    New Zealand
    Turkey
    United Kingdom
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 180
    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)
    none
    nessuno
    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 Decision2019-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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