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    The EU Clinical Trials Register currently displays   37504   clinical trials with a EudraCT protocol, of which   6153   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-001680-72
    Sponsor's Protocol Code Number:TAK-390MR_206
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-10-17
    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 number2012-001680-72
    A.3Full title of the trial
    A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the safety and
    Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-
    Release Capsules for Relief of Heartburn, in Adolescent subjects Aged 12 to
    17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
    studio multicentrico di 4 settimane in aperto, di fase II, per valutare la sicurezza e l’efficacia della somministrazione orale giornaliera delle capsule di dexlansoprazolo a rilascio prolungato per il trattamento del bruciore di stomaco in soggetti adolescenti di età compresa tra 12 e 17 anni affetti da malattia da reflusso gastroesofageo sintomatica non erosiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    4 week study to assess safety and effectiveness of Dexlansoprazole
    capsules for relief of heartburn in subjects aged 12-17 with symptomatic
    acid reflux disease.
    studio di 4 settimane per valutare la sicurezza e l'efficacia di dexlansoprazolo in capsule per il trattamento del bruciore di stomaco in soggetti di età compresa tra i 12 e i 17 anni affetti da malattia da reflusso gastroesofageo sintomatica.
    A.4.1Sponsor's protocol code numberTAK-390MR_206
    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 EUROPE RESEARCH & DEVELOPMENT CENTRE 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 Global Research & Development Centre (Europe)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Global Research & 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 Dexlansoprazolo
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharmaceuticals U.S.A.,
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 INNDexlansoprazolo
    D.3.9.1CAS number 138530-94-6
    D.3.9.2Current sponsor codeTAK-390
    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
    Heartburn in Adolescent subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
    Bruciore di stomaco in soggetti adolescenti di età compresa tra 12 e 17 anni affetti da malattia da reflusso gastroesofageo sintomatica non erosiva
    E.1.1.1Medical condition in easily understood language
    Heartburn in Adolescent Subjects With Acid Reflux Disease
    Bruciore di stomaco in soggetti adolescenti affetti da malattia da reflusso gastroesofageo
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10018203
    E.1.2Term GERD
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10042079
    E.1.2Term Stomach burning sensation of
    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 safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules (30 mg) in adolescent subjects aged 12 to 17 years, with symptomatic non-erosive GERD.
    valutare la sicurezza e l’efficacia del trattamento con monosomministrazione giornaliera orale di capsule di dexlansoprazolo a rilascio prolungato (30 mg) in soggetti adolescenti di età compresa tra i 12 e i 17 anni affetti da malattia da GERD sintomatica non erosiva.
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subjects must be aged between 12 and 17 years (inclusive) and have a history of symptoms of gastroesophageal reflux disease (GERD) at least 3 months prior to screening, based on assessments of the investigator. To be enrolled in the study, patients must have heartburn for at least 3 days out of 7 during the screening period, bringing in the daily electronic diary.
    I soggetti devono avere un’età compresa tra i 12 e i 17 anni (compresi) e avere un’anamnesi di sintomi di malattia da reflusso gastroesofageo (GERD) di almeno 3 mesi precedenti allo screening, in base alle valutazioni dello sperimentatore. Per essere arruolati allo studio, i pazienti devono avere bruciori di stomaco per almeno 3 giorni su 7 durante il periodo di screening, riportandolo nel diario quotidiano elettronico.
    E.4Principal exclusion criteria
    patients with erosive esophagitis. Subjects with a history of hypersensitivity or allergic to dexlansoprazolo, any of its components, antacids or any proton pump inhibitor (PPI) (including lansoprazole, omeprazole, rabeprazole, pantoprazole and esomeprazole). Subjects who show evidence of cardiovascular, pulmonary, central nervous system, liver, hematopoietic, renal, metabolic, endocrine or gastrointestinal, or with severe allergies, asthma or skin rashes suggestive of allergic origin of diseases or conditions are not controlled and significant (different from the disease under study) that could interfere with the ability to participate in the subject or potentially confuse the results of the study, or clinically important findings arising from the results of physical examination or laboratory analysis, in the opinion of the investigator. Persons who must take prescription drugs or over the counter drugs and treatments listed in the section except the protocol (Section 7.3).
    Soggetti affetti da esofagite erosiva. Soggetti con una storia di ipersensibilità o di allergie nei confronti di dexlansoprazolo, di qualsiasi dei suoi componenti, di antiacidi o di qualsiasi inibitore di pompa protonica (PPI) (compresi lansoprazolo, omeprazolo, rabeprazolo, pantoprazolo o esomeprazolo). Soggetti che mostrano evidenze di malattie cardiovascolari, polmonari, del sistema nervoso centrale, epatiche, ematopoietiche, renali, metaboliche, endocrine o gastrointestinali, oppure affetti da gravi allergie, asma o eruzioni cutanee di origine allergica suggestive di patologie o condizioni non controllate e significative (diverse dalla patologia in studio), che potrebbero interferire con la capacità di partecipazione del soggetto o confondere potenzialmente i risultati dello studio oppure delle scoperte clinicamente importanti derivanti dall’esame obiettivo o dai risultati delle analisi di laboratorio, secondo il giudizio dello sperimentatore. Soggetti che devono assumere farmaci su prescrizione o da banco elencati nella sezione Farmaci e trattamenti esclusi del protocollo (Sezione 7.3).
    E.5 End points
    E.5.1Primary end point(s)
    Treatment-emergent adverse events (TEAE) experienced by ≥5% of subjects while receiving dexlansoprazole during the 4 week Treatment Period.
    l’endpoint primario di questo studio è stabilire gli eventi avversi causati dal trattamento (treatment-emergent adverse events – TEAE) sperimentati da una percentuale ≥5% dei soggetti trattati con dexlansoprazolo nel periodo di trattamento di 4 settimane.
    E.5.1.1Timepoint(s) of evaluation of this end point
    An electronic daily diary is maintained and a full examination and evaluation of end points takes place during week 4 of treatment at the final visit
    E' tenuto un diario elettronico giornaliero e si svolgono un esame ed una valutazione completi dei punti finali durante la settimana 4 di trattamento all'ultima visita
    E.5.2Secondary end point(s)
    The percentage of days with neither daytime nor nighttime heartburn over the 4 weeks of treatment as assessed by electronic daily diary.
    L’endpoint secondario di questo studio è stabilire la percentuale di giornate in assenza di bruciori di stomaco sia diurni sia notturni durante le 4 settimane di trattamento, sulla base del diario elettronico quotidiano.
    E.5.2.1Timepoint(s) of evaluation of this end point
    An electronic daily diary is maintained and a full examination and evaluation of end points takes place during week 4 of treatment at the final visit
    E' tenuto un diario elettronico giornaliero e si svolgono un esame ed una valutazione completi dei punti finali durante la settimana 4 di trattamento all'ultima visita
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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
    Brazil
    Mexico
    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 years0
    E.8.9.1In the Member State concerned months11
    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 months19
    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: 100
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 100
    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)
    As per protocol, the subject should be returned to the care of a physician and standard therapies as required after completion of participation in the study.
    Come da protocollo, il soggetto deve essere restituito alla cura di un medico e terapie standard, come richiesto dopo il completamento della partecipazione allo studio.
    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 Decision2013-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-20
    P. End of Trial
    P.End of Trial StatusOngoing
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