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    EudraCT Number:2016-003775-22
    Sponsor's Protocol Code Number:D961TC00002
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-11-03
    Trial results View results
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    A. Protocol Information
    A.2EudraCT number2016-003775-22
    A.3Full title of the trial
    An Open-label, parallel-group, multi-centre, phase I / III study to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once-daily oral administration of 961H 10 mg and D961H 20 mg in Japanese paediatric patients 1 to 14 years old with gastrointestinal acid related diseases
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    phase I / III study to assess the safety, pharmacokinetics, pharmacodynamics and efficacy in Japanese paediatric patients
    A.4.1Sponsor's protocol code numberD961TC00002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02153398
    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 SponsorAstraZeneca K.K.
    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 supportAstraZeneca
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca K.K.
    B.5.2Functional name of contact pointClinical Operation Division
    B.5.3 Address:
    B.5.3.1Street AddressGrand Front Osaka Tower B, 3-1
    B.5.3.2Town/ cityOfuka-cho, Kita-ku, Osaka
    B.5.3.3Post code530-0011
    B.5.4Telephone number81677114669
    B.5.5Fax number81648023563
    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 namenexium
    D.3.2Product code D961H
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Japanese paediatric patients 1 to 14 years old with gastrointestinal acid related diseases
    E.1.1.1Medical condition in easily understood language
    gastrointestinal acid related diseases
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety and tolerability of repeated oncedaily oral administration of D961H 10 mg and D961H 20 mg
    E.2.2Secondary objectives of the trial
    PK, PD, Efficacy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ・Provision of signed written informed consent from the patient’s guardian (including informed consent to a genetic test) prior to conducting of any study-related procedure and assent from the patient if possible.
    ・Patients aged ≥ 1 year to 14 years old inclusive at the time of informed consent.
    ・Patients who have a diagnosis of or suspected to have GU, DU, AU, NERD, RE or Zollinger-Ellison syndrome.
    ・Patient’s BMI must be between the 10th and 90th percentile for his/her age.
    E.4Principal exclusion criteria
    ・Patients less than 10 kg in weight.
    ・Use of any other investigational compounds or participations in another clinical trial within 4 weeks prior to the randomisation/registration.
    ・Significant clinical illness within 4 weeks prior to the randomisation/registration, e.g., unintentional weight loss, gastrointestinal bleeding requiring abstinence from food, jaundice, or any other signs indicating serious or malignant diseases.
    ・Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by the investigators.
    ・Positive for pregnancy test by urinary or lactation for post-menarchal females
    ・Previous total gastrectomy
    ・Need for H. pylori eradication therapy during the study period.
    ・Use of any PPIs within 14 days prior to the randomisation/registration.
    E.5 End points
    E.5.1Primary end point(s)
    safety and tolerability by the assessment of adverse events, laboratory variables and vital signs
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the study period including run-in or washout periods
    E.5.2Secondary end point(s)
    − To assess the pharmacokinetics with the PK parameters [AUCtau (AUC during a dosing interval), AUC 0-t, Cmax, tmax, t1/2, apparent total clearance (CL/F) and apparent volume of distributionduring terminal phase (Vz/F)] of esomeprazole
    − To assess the pharmacokinetics with the PK parameters (AUCtau, AUC0-t, Cmax, tmax, and t1/2) of the 5-hydroxy and sulphone metabolites of esomeprazole

    − To assess percentages of time with intragastric pH > 4 and pH > 3, and median intragastric pH during 12-hours by intragastric pH monitoring

    • Efficacy
    − To assess the clinical outcome by the assessment of presence /absence and severity of upper gastrointestinal symptoms (heartburn, epigastric pain, upper abdominal discomfort and regurgitation).
    E.5.2.1Timepoint(s) of evaluation of this end point
    after at least 5 days of repeated oral administration of D961H 10 mg and D961H 20 mg.

    at pre-dose and after at least 5 days of repeated oral administration of D961H 10 mg and D961H 20 mg in a subset of subjects.

    • Efficacy
    compared to baseline after 1, 4 and 8 weeks administration of D961H 10 mg and D961H 20 mg.
    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 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. trial type description
    PK/PD study
    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 No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 50
    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. of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F. of subjects for this age range: 28
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 20
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 50
    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)
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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