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    Summary
    EudraCT Number:2014-001642-16
    Sponsor's Protocol Code Number:TAK-390MR_108
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2015-01-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-001642-16
    A.3Full title of the trial
    A Phase 1, Randomized, Open-Label, Parallel-Design, Multicenter Study to Evaluate the
    Pharmacokinetics, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release
    Capsules in Infants Aged 1 to 11 Months With Acid-Related Diseases
    Studio multicentrico di Fase 1, randomizzato, in aperto, a disegno parallelo per valutare la farmacocinetica, la sicurezza e la farmacodinamica di capsule di dexlansoprazolo a rilascio ritardato in neonati di età compresa tra 1 e 11 mesi con patologie acido-correlate
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants
    Aged 1 to 11 Months
    Fase 1 capsule di dexlansoprazolo a rilascio ritardato in neonati di età compresa tra 1 e 11 mesi con patologie acido-correlate
    A.4.1Sponsor's protocol code numberTAK-390MR_108
    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 SponsorTakeda Development Centre Europe Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportTakeda Development Center Americas, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Centre Europe Ltd.
    B.5.2Functional name of contact pointProgram Manager
    B.5.3 Address:
    B.5.3.1Street Address61 Aldwych
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC2B 4AE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044 020 3116 8000
    B.5.5Fax number0044 020 3116 8199
    B.5.6E-mailclinicaloperations@tgrd.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 Dexlansoprazole Delayed-Release Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Italia 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.3.1Product nameDexlansoprazole Delayed-Release Capsules
    D.3.2Product code TAK-390MR
    D.3.4Pharmaceutical form Capsule
    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 INNDexlansoprazole
    D.3.9.1CAS number 138530-94-6
    D.3.9.3Other descriptive nameDEXLANSOPRAZOLE
    D.3.9.4EV Substance CodeSUB31929
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 Dexlansoprazole Delayed-Release Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Italia 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.3.1Product nameDexlansoprazole Delayed-Release Capsules
    D.3.2Product code TAK-390MR
    D.3.4Pharmaceutical form Capsule
    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 INNDexlansoprazole
    D.3.9.1CAS number 138530-94-6
    D.3.9.3Other descriptive nameDEXLANSOPRAZOLE
    D.3.9.4EV Substance CodeSUB31929
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Dexlansoprazole Delayed-Release Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Italia 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.3.1Product nameDexlansoprazole Delayed-Release Capsules
    D.3.2Product code TAK-390MR
    D.3.4Pharmaceutical form Capsule
    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 INNDexlansoprazole
    D.3.9.1CAS number 138530-94-6
    D.3.9.3Other descriptive nameDEXLANSOPRAZOLE
    D.3.9.4EV Substance CodeSUB31929
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Dexlansoprazole Delayed-Release Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Italia 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.3.1Product nameDexlansoprazole Delayed-Release Capsules
    D.3.2Product code TAK-390MR
    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 INNDexlansoprazole
    D.3.9.1CAS number 138530-94-6
    D.3.9.3Other descriptive nameDEXLANSOPRAZOLE
    D.3.9.4EV Substance CodeSUB31929
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acid-Related Disorders in Infants aged 1 to 11 months
    patologie acido-correlate in neonati di età compresa tra 1 e 11 mesi
    E.1.1.1Medical condition in easily understood language
    Acid-Related Disorders in Infants
    patologie acido-correlate in neonati
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10066874
    E.1.2Term Gastroesophageal reflux disease
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10000479
    E.1.2Term Acid reflux (oesophageal)
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10019326
    E.1.2Term Heartburn
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10063657
    E.1.2Term Erosive esophagitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the PK of dexlansoprazole after daily administration for 7 days in pediatric subjects aged 1 to 11 months, inclusive, with acid-related diseases.

    To assess the safety of dexlansoprazole in pediatric subjects aged 1 to 11 months, inclusive, after daily administration for 8 weeks.

    To assess the PD of dexlansoprazole after daily administration for 7 days in pediatric subjects aged 1 to 11 months, inclusive, with acid-related diseases.
    • Valutare la PK di dexlansoprazolo dopo somministrazione giornaliera per 7 giorni in soggetti pediatrici di età compresa tra 1 e 11 mesi, inclusi, con patologie acido-correlate.
    • Valutare la sicurezza di dexlansoprazolo in soggetti pediatrici di età compresa tra 1 e 11 mesi, inclusi, dopo somministrazione giornaliera per 8 settimane.
    • Valutare la PD di dexlansoprazolo dopo somministrazione giornaliera per 7 giorni in soggetti pediatrici di età compresa tra 1 e 11 mesi, inclusi, con patologie acido-correlate
    E.2.2Secondary objectives of the trial
    none
    nessuno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility is determined according to the following criteria:
    1. Prior to any study-specific procedures being performed and after having the study fully explained and all questions answered, the informed consent form (ICF) must be signed and dated by parent(s) or legal guardian(s). Screening Period starts at the time of consent.
    2. Subject is a male or female infant 1 to 11 months old, inclusive, on Day 1. Infants who were born prematurely must be ≥45 weeks old based on corrected gestational age.
    3. At the Initial Screening and Day -1 visits, subject must have body weight percentile-for-age within the 5th through 95th percentile by age, inclusive, as determined by the WHO growth chart.
    4. Subjects must be ≥3.4 kg at the Screening and Day -1 visits.
    5. Subjects who take prescription or nonprescription PPIs, histamine-2 receptor antagonists (H2RAs), sucralfate, or antacids on a regular or as required basis must agree to discontinue use on Day -1 (except cimetidine, which must be discontinued 28 days prior to Day -1), and agree to discontinue use throughout the study.
    6. Subject must have endoscopically proven EE, a history of EE, and/or the subject has 1 or more of the following underlying conditions that predispose the subject to chronic GERD and EE: moderate to severe neurologic impairment, repaired esophageal atresia, hiatal hernia, cystic fibrosis, bronchopulmonary dysplasia, or end-stage renal disease.
    7. Except for subjects with EE, history of EE, or repaired esophageal atresia, subjects have:
    - Received prior PPI therapy for a minimum of 2 weeks during any time in the past with symptomatic response and have demonstrated a recurrence of symptoms following at least 1 attempted withdrawal of PPI therapy
    AND
    - Have undergone esophageal pH monitoring in the recent past to document that their symptoms are due to acid-mediated disease.
    8. Subject must be able to ingest study medication granules sprinkled on 1 tablespoon of applesauce or pureed apples, or as a mixture of granules in water administered via oral syringe.
    9. Subject must be at least 7 days postsurgery by dosing on Day 1 and have no anticipated need for surgery during the study.
    10. Screening laboratory samples must be collected between Day -7 and Day -2 and the results must be within the range expected for this infant population (except gastrin and hepatitis panel results as those results will be available after Day 1). The laboratory results should indicate no CS abnormality in chemistry (including electrolytes, blood urea nitrogen [BUN]), creatinine, glucose, ALT, AST, and total bilirubin), hematology (complete blood cell count, including differential), and urinalysis parameters (if standard of care).
    L’eleggibilità dei soggetti è determinata in base ai seguenti criteri:
    1. Prima che venga svolta qualsiasi procedura studio specifica e dopo che lo studio è stato completamente spiegato e si è risposto a tutte le domande, il modulo di consenso informato (ICF) deve essere firmato e datato dai genitori o dai tutori legali. Il periodo screening inizia al momento del consenso.
    2. Al Giorno 1 i soggetti di sesso maschile o femminile devono avere un’età compresa tra 1 e 11 mesi, inclusi. I bambini nati prematuramente devono essere ≥45 settimane sulla base della corretta età gestazionale.
    3. Alla visita di screening e del Giorno -1, il peso corporeo deve essere compreso tra il 5° e il 95° percentile per l’età, inclusi, come stabilito in base alle tabelle di crescita dell’OMS
    4. I soggetti devono pesare ≥3.4 kg allo screening e al Giorno -1.
    5. I soggetti che prendono inibitori della pompa protonica su prescrizione o senza ricetta medica, antagonisti del recettore H2 dell’istamina (H2RAs), sucralfato o antiacidi su base regolare normaleo come richiesto deve accettare di interromperne l'uso il giorno -1 (tranne la cimetidina, che deve essere interrotta 28 giorni prima Giorno -1), e accettare di interromperne l'uso nel corso dello studio.
    6. I soggetti devono presentare un’esofagite erosiva (EE) endoscopicamente comprovata, un’anamnesi di EE oppure 1 o più delle seguenti condizioni di base predisponenti a GERD ed EE croniche: disfunzione neurologica da moderata a grave, atresia esofagea sottoposta a correzione, ernia iatale, fibrosi cistica, displasia broncopolmonare o malattia renale allo stadio terminale.
    7. Fatta eccezione per i soggetti con EE, anamnesi di EE o atresia esofagea corretta, i soggetti devono
    - aver ricevuto una precedente terapia con inibitore della pompa protonica (proton pump inhibitor, PPI) per almeno 2 settimane in qualunque momento nel passato, con risposta sintomatica e aver dimostrato una recidiva sintomatica dopo almeno 1 tentativo di interruzione della terapia con PPI
    ED
    - essersi recentemente sottoposti a monitoraggio del pH esofageo per documentare la relazione causale dei sintomi con la patologia acido-correlata.
    8. Il soggetto deve essere in grado di ingerire i granuli del farmaci dello studio sparsi su 1 cucchiaio di purè di mela/mele grattugiate, o i granuli miscelati con acqua somministrati con una siringa per via orale.
    9. devono essere passati almeno 7 giorni da qualunque intervento chirurgico per il dosaggio al giorno 1 e non deve essere in previsione alcun intervento chirurgico durante il periodo dello studio.
    10. I campioni di laboratorio per lo Screening devono essere raccolti tra il giorno -7 e il Giorno -2 e i risultati devono essere nel range previsto per questa popolazione di neonati (ad eccezione della gastrina e dei risultati del pannello per l’epatite, che saranno disponibili dopo il giorno 1). I risultati di laboratorio devono indicare nessuna anomalia chimica clinicamente rilevante (compresi gli elettroliti, azotemia [BUN], creatinina, glucosio, ALT, AST e bilirubina totale), negli esami ematologici (conta delle cellule del sangue completo, compreso differenziale), e nei parametri delle analisi delle urine (se terapia standard).
    E.4Principal exclusion criteria
    A subject who meets any of the following criteria will not qualify for entry into the study:
    1. Subject has evidence of cardiovascular, pulmonary, central nervous system, hepatic, hematopoietic, renal, metabolic, endocrine or gastrointestinal disease, or serious allergy, asthma, or allergic skin rash that suggests CS, uncontrolled underlying disease or condition (other than the disease being studied and/or identified as the main criterion for inclusion), that may impact the ability of the subject to participate or potentially may confound the study results.
    2. Subject has known history of or current presence of peptic ulcers or gastrointestinal bleeding (hematemesis, hematochezia).
    3. Subject has poor venous access or any contraindication to blood sampling.
    4. Subject has known history of eosinophilic gastroenteropathy, or a coexisting disease affecting the esophagus, including esophageal varices, viral or fungal infection, or esophageal stricture, history of radiation therapy or cryotherapy to the esophagus, and caustic or physiochemical trauma such as sclerotherapy to the esophagus.
    5. Subject has active malabsorption syndrome, cow’s milk intolerance, milk protein allergy, or celiac disease.
    6. Subject has any finding in his/her medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of a disease that might interfere with the conduct of the study or that would contraindicate taking dexlansoprazole delayed-release capsules or a similar drug in the same class (ie, PPIs).
    7. Subject has a known hypersensitivity to any PPI or any component of the formulation of dexlansoprazole delayed-release capsules (see most current version of the Dexilant Full Prescribing Information).
    8. The subject is required to take excluded medications or it is anticipated that the subject will require treatment with at least 1 of the disallowed concomitant medications during the study evaluation period as specified in the Excluded Medications and Dietary Products.
    9. Subject has a history of malignant disease.
    10. Subject has a known history of infection with the human immunodeficiency virus.
    11. Subject has lost >10% of the total blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study medication.
    12. Subject has consumed products detailed in Section 7.3, Excluded Medications and Dietary Products during the time periods listed, or parent(s) or legal guardian(s) is unwilling to agree to subject abstaining from products listed in Section 7.3 while participating in the study.
    13. Subject has participated in a study of an investigational agent (including dosing or follow-up) within 30 days prior to Screening.
    14. Subject has a Screening Visit laboratory value that the principal investigator and sponsor consider to be CS.
    15. The subject has: creatinine >1.5 mg/dL, ALT and/or AST >2 times the ULN, or total bilirubin >2.0 mg/dL with AST/ALT elevated above the limits of normal values.
    16. The subject or parent/legal guardian is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study or may consent under duress.
    17. Parent/legal guardian, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
    18. Subject has any congenital anomaly of the upper gastric intestinal tract that might interfere with gastrointestinal motility, pH, or absorption, or has an active or known history of necrotizing enterocolitis that has been surgically corrected.
    19. Subject has clinical evidence of acute sepsis. Infants on chronic antibiotics who are otherwise clinically stable may be enrolled in the study at the discretion of the investigator.
    20. Subject has received a vaccine within 48 hours prior to dosing on Day 1.
    21. Subject has used intravenous or oral antifungal agents within the 7 days prior to Day -1.
    22. Subject has used mucosal protective agent (eg, sucralfate) within 6 hours prior to dosing on Day 1.
    Un soggetto che risponde ai seguenti criteri non è qualificato per essere arruolato nello studio:
    1. Soggetti con evidenza di malattia cardiovascolare, polmonare, del sistema nervoso centrale, epatica, del sistema emopoietico, renale, metabolica, endocrina o gastrointestinale, o di grave allergia, asma o eruzione cutanea allergica suggestiva di patologia o condizione sottostante non controllata e clinicamente significativa (diversa dalla malattia in studio e/o identificata come criterio principale per l’inclusione), che possano influire sulla capacità del soggetto di partecipare allo studio o potenzialmente confondere i risultati dello studio.
    2. soggetto con anamnesi nota di ulcera peptica o sanguinamento gastrointestinale (ematemesi, ematochezia).
    3. Il soggetto presenta scarso accesso venoso o qualsiasi controindicazione al prelievo di sangue.
    4. Soggetto con anamnesi nota di gastroenteropatia eosinofila, o coesistente malattia che colpisce l'esofago, tra cui varici esofagee, infezione virale o fungina, o stenosi esofagea, anamnesi di radioterapia o crioterapia all'esofago, e trauma caustica o fisiochimico quali scleroterapia all'esofago.
    5. soggetto con sindrome da malassorbimento attiva, intolleranza al latte di mucca, allergia alle proteine del latte, o celiachia.
    6. soggetto con qualsiasi elemento conoscitivo nella sua anamnesi, esame fisico, o analisi cliniche di laboratorio di sicurezza che fornisca un ragionevole dubbio della presenza di una malattia che potrebbe interferire con la conduzione dello studio o che possa rappresentare una controindicazione all’assunzione di dexlansoprazolo a rilascio ritardato in capsule o di un farmaco simile della stessa classe (cioè, IPP).
    7. soggetto con ipersensibilità a qualsiasi PPI o qualsiasi componente della formulazione in capsule di dexlansoprazolo a rilascio ritardato (vedi la versione più attuale del Riassunto delle caratteristiche del prodotto (RCP) di Dexilant).
    8. Il soggetto è tenuto a prendere i farmaci proibiti o si prevede che il soggetto dovrà essere trattato con almeno 1 dei farmaci concomitanti non consenititi durante il periodo di valutazione di studio come specificato nella sezione farmaci proibiti e prodotti dietetici.
    9.Il soggetto presenta un’anamnesi di neoplasia maligna
    10. Il soggetto presenta un’anamnesi nota di infezione da HIV
    11. Il soggetto ha perso> 10% del volume totale del sangue, in seguito a plasmaferesi, o ha subito una trasfusione di qualsiasi prodotto ematico entro 90 giorni prima della prima dose del farmaco in studio.
    12. Il soggetto ha consumato prodotti dettagliati nella Sezione 7.3, farmaci proibiti e prodotti dietetici durante i periodi di tempo elencati, o i genitori o i tutori legali non sono disposti ad accettare che l’infante si astenga dall’assunzione dei prodotti elencati nella sezione 7.3 durante la partecipazione allo studio.
    13. Il soggetto ha partecipato a uno studio con un farmaco sperimentale (compresi di dosaggio o di follow-up) nei 30 giorni prima dello screening.
    14. Il soggetto alla visita di screening presenta un valore di laboratorio che lo sperimentatore principale e lo sponsor considerano clinicamente rilevante.
    15. Il soggetto presenta: creatinina> 1,5 mg / dL, ALT e / o AST> 2 volte l'ULN, o bilirubina totale> 2,0 mg / dL con AST / ALT elevato al di sopra dei limiti dei valori normali.
    16. Il soggetto o il genitore / tutore legale è un parente stretto di un membro, dipendente del centro presso cui si svolge lo studio, o è in un rapporto di dipendenza con un dipendente del centro, che è coinvolto nella conduzione di questo studio o può
    acconsentire sotto costrizione.
    17. Il genitore / tutore legale, a giudizio dello sperimentatore, è improbabile che rispetti il protocollo o è inadatto per qualsiasi altra ragione.
    18. Il soggetto presenta anomalia congenita intestinale del tratto gastrico superiore che potrebbe interferire con la motilità gastrointestinale, pH, o l’assorbimento, o ha un’anamnesi attiva o nota di enterocolite necrotizzante che è stata corretta chirurgicamente.
    19. il soggetto presenta evidenza clinica di sepsi acuta. I neonati con somministrazione cronica di antibiotici che sono comunque clinicamente stabili possono essere arruolati nello studio a discrezione dello sperimentatore.
    20. Il soggetto ha ricevuto un vaccino entro 48 ore prima della somministrazione al Giorno 1.
    21. Il soggetto ha utilizzato agenti antifungini per via endovenosa o per via orale nei 7
    giorni prima del giorno -1.
    22. Il soggetto ha utilizzato un agente protettivo delle mucose (ad esempio, sucralfato) entro 6 ore prima della somministrazione al Day 1
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of this study will be the following dexlansoprazole PK parameters
    derived on Confinement Day 1:
    • Maximum observed plasma concentration (Cmax).
    • Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration (AUCt) and area under the plasma concentration-time curve during a dosing interval, where tau (τ) is the length of the dosing interval (AUCτ).
    • Dose-normalized Cmax and area under the plasma concentration-time curves (AUCs).
    • The difference in the percent of time with intragastric pH>4 during the 24-hour period on Day -1 (Baseline) and on Confinement Day 1 postdose.
    • The difference in 24-hour mean intragastric pH on Day -1 (Baseline) and postdose on Confinement Day 1.
    Gli endpoints primari di questo studio saranno i seguenti parametri PK per il dexlansoprazolo al Giorno 1 di isolamento:
    • concentrazione plasmatica massima (Cmax) osservata
    • area sotto la curva concentrazione plasmatica-tempo dal tempo 0 al tempo dell’ultima concentrazione quantificabile (AUCt), area sotto la curva concentrazione plasmatica-tempo durante un intervallo di somministrazione, dove tau () rappresenta la lunghezza dell’intervallo di somministrazione (AUC)
    • Cmax e area sotto le curve concentrazione plasmatica-tempo (concentration-time curves, AUC) normalizzate per la dose
    • La differenza nella percentuale di tempo con pH intragastrico >4 per un periodo di 24 ore al Giorno -1 (basale) e postdose al Giorno 1 di isolamento.
    • La differenza per un periodo di 24 ore del pH intragastrico mediano al Giorno -1 (basale) e postdose al Giorno 1 di isolamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Day 7
    al basale e al Giorno 7
    E.5.2Secondary end point(s)
    none
    nessuno
    E.5.2.1Timepoint(s) of evaluation of this end point
    none
    nessuno
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety, PK and PD
    Sicurezza, PK e PD
    E.7.2Therapeutic exploratory (Phase II) No
    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 Yes
    E.8.2.3.1Comparator description
    Disegno parallelo, dosi multiple comparative dello stesso IMP
    Parallel design, multiple comparative doses of same IMP
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Israel
    Italy
    Mexico
    Poland
    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
    LPLV
    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 months10
    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 Yes
    F.1.1Number of subjects for this age range: 24
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 24
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) 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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    infant
    neonati
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 24
    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 Decision2015-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-04
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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