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    Clinical Trial Results:
    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 D961H 10 mg and D961H 20 mg in Japanese paediatric patients 1 to 14 years old with gastrointestinal acid related diseases

    Summary
    EudraCT number
    2016-003775-22
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    25 Aug 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Dec 2016
    First version publication date
    08 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D961TC00002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca Japan
    Sponsor organisation address
    Grand Front Osaka Tower B. 3-1, Ofuka-cho, Kita-ku, Osaka, Japan, 530-0011
    Public contact
    Yu Shimizuishi, Clinical operation departmnet, 81 677114669, Yu.Shimizuishi@astrazeneca.com
    Scientific contact
    Masahiro Nii, Biometrics Department, 81 677114571, Masahiro.Nii@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Aug 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the safety and tolerability of repeated once-daily oral administration of D961H 10 mg and D961H 20 mg by the assessment of adverse events, laboratory variables and vital signs in Japanese paediatric patients aged 1 to 14 years old who either had a diagnosis of or were suspected to have gastric ulcer, duodenal ulcer, Anastomotic ulcer, non-erosive reflux disease, reflux esophagitis or Zollinger-Ellison syndrome.
    Protection of trial subjects
    Nothing special
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Jun 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    2
    Children (2-11 years)
    28
    Adolescents (12-17 years)
    20
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The patients were enrolled from 20 sites in Japan from 24 June 2014 to 4 April 2016. Of the 55 patients screened for the study, 50 patients were eligible for the participation and were registered into the study.

    Pre-assignment
    Screening details
    55 patients were screened. Out of the 55 screened patients, 5 patients were not registered into the study because thet did not meet inclusion/exclusion criteria.

    Pre-assignment period milestones
    Number of subjects started
    50
    Number of subjects completed
    50

    Period 1
    Period 1 title
    8 week treatment (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    This study was open.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Group 1
    Arm description
    D961H sachet 10 mg Age: 1-11 years and Weight <20 kg
    Arm type
    Experimental

    Investigational medicinal product name
    D961H
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    sachet 10 mg once daily

    Arm title
    Group 2
    Arm description
    D961H capsule 10 mg Age: 1-11 years and Weight >=20 kg
    Arm type
    Experimental

    Investigational medicinal product name
    D961H
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg once daily

    Arm title
    Group 3
    Arm description
    D961H capsule 20 mg Age: 1-11 years and Weight: >=20 kg
    Arm type
    Experimental

    Investigational medicinal product name
    D961H
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg once daily

    Arm title
    Group 4
    Arm description
    D961H capsule 10 mg Age: 12-14 years and Weight: >=20 kg
    Arm type
    Experimental

    Investigational medicinal product name
    D961H
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg once daily

    Arm title
    Group 5
    Arm description
    D961H capsule 20 mg Age: 12-14 years and Weight: >=20 kg
    Arm type
    Experimental

    Investigational medicinal product name
    D961H
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg once daily

    Number of subjects in period 1
    Group 1 Group 2 Group 3 Group 4 Group 5
    Started
    10
    10
    10
    10
    10
    Completed
    9
    10
    9
    9
    10
    Not completed
    1
    0
    1
    1
    0
         Adverse event, non-fatal
    -
    -
    1
    -
    -
         Consent withdrawn by subject
    1
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    D961H sachet 10 mg Age: 1-11 years and Weight <20 kg

    Reporting group title
    Group 2
    Reporting group description
    D961H capsule 10 mg Age: 1-11 years and Weight >=20 kg

    Reporting group title
    Group 3
    Reporting group description
    D961H capsule 20 mg Age: 1-11 years and Weight: >=20 kg

    Reporting group title
    Group 4
    Reporting group description
    D961H capsule 10 mg Age: 12-14 years and Weight: >=20 kg

    Reporting group title
    Group 5
    Reporting group description
    D961H capsule 20 mg Age: 12-14 years and Weight: >=20 kg

    Reporting group values
    Group 1 Group 2 Group 3 Group 4 Group 5 Total
    Number of subjects
    10 10 10 10 10 50
    Age Categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    2 0 0 0 0 2
        Children (2-11 years)
    8 10 10 0 0 28
        Adolescents (12-17 years)
    0 0 0 10 10 20
        Adults (18-64 years)
    0 0 0 0 0 0
        From 65-84 years
    0 0 0 0 0 0
        85 years and over
    0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    3.6 ± 2.2 8.9 ± 0.7 8.4 ± 1.8 13.4 ± 0.7 13.1 ± 0.9 -
    Gender Categorical
    Units: Subjects
        Female
    5 6 2 7 6 26
        Male
    5 4 8 3 4 24

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    D961H sachet 10 mg Age: 1-11 years and Weight <20 kg

    Reporting group title
    Group 2
    Reporting group description
    D961H capsule 10 mg Age: 1-11 years and Weight >=20 kg

    Reporting group title
    Group 3
    Reporting group description
    D961H capsule 20 mg Age: 1-11 years and Weight: >=20 kg

    Reporting group title
    Group 4
    Reporting group description
    D961H capsule 10 mg Age: 12-14 years and Weight: >=20 kg

    Reporting group title
    Group 5
    Reporting group description
    D961H capsule 20 mg Age: 12-14 years and Weight: >=20 kg

    Primary: Disappearance of heartburn at Week 8 by patient diaries

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    End point title
    Disappearance of heartburn at Week 8 by patient diaries [1]
    End point description
    The disappearance of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of heartburn were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    2
    3
    1
    1
    4
    Units: Participants
    2
    0
    0
    1
    3
    No statistical analyses for this end point

    Primary: Disappearance of epigastric pain at Week 8 by patient diaries

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    End point title
    Disappearance of epigastric pain at Week 8 by patient diaries [2]
    End point description
    The disappearance of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of epigastric pain were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    2
    6
    5
    4
    7
    Units: Participants
    2
    3
    5
    1
    3
    No statistical analyses for this end point

    Primary: Disappearance of upper abdominal discomfort at Week 8 by patient diaries

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    End point title
    Disappearance of upper abdominal discomfort at Week 8 by patient diaries [3]
    End point description
    The disappearance of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of upper abdominal discomfort were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    3
    6
    4
    4
    6
    Units: Participants
    3
    2
    4
    2
    2
    No statistical analyses for this end point

    Primary: Disappearance of regurgitation at Week 8 by patient diaries

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    End point title
    Disappearance of regurgitation at Week 8 by patient diaries [4]
    End point description
    The disappearance of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of regurgitation were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    4
    3
    5
    3
    4
    Units: Participants
    3
    2
    3
    2
    4
    No statistical analyses for this end point

    Primary: Aggravation of heartburn at Week 8 by patient diaries

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    End point title
    Aggravation of heartburn at Week 8 by patient diaries [5]
    End point description
    The aggravation of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of heartburn were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    7
    7
    8
    8
    6
    Units: Participants
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Aggravation of epigastric pain at Week 8 by patient diaries

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    End point title
    Aggravation of epigastric pain at Week 8 by patient diaries [6]
    End point description
    The aggravation of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of epigastric pain were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    7
    4
    4
    5
    3
    Units: Participants
    0
    0
    1
    1
    1
    No statistical analyses for this end point

    Primary: Aggravation of upper abdominal discomfort at Week 8 by patient diaries

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    End point title
    Aggravation of upper abdominal discomfort at Week 8 by patient diaries [7]
    End point description
    The aggravation of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of upper abdominal discomfort were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    6
    4
    5
    5
    4
    Units: Participants
    0
    0
    2
    1
    0
    No statistical analyses for this end point

    Primary: Aggravation of regurgitation at Week 8 by patient diaries

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    End point title
    Aggravation of regurgitation at Week 8 by patient diaries [8]
    End point description
    The aggravation of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of regurgitation were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    5
    7
    4
    6
    6
    Units: Participants
    2
    0
    1
    0
    0
    No statistical analyses for this end point

    Primary: Disappearance of heartburn at Week 8 by investigators

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    End point title
    Disappearance of heartburn at Week 8 by investigators [9]
    End point description
    The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of heartburn were defined as those who had a heartburn at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    2
    2
    0 [10]
    2
    3
    Units: Participants
    2
    1
    2
    2
    Notes
    [10] - No patient had the corresponding symtom at pre-dose.
    No statistical analyses for this end point

    Primary: Disappearance of epigastric pain at Week 8 by investigators

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    End point title
    Disappearance of epigastric pain at Week 8 by investigators [11]
    End point description
    The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of epigastric pain were defined as those who had an epigastric pain at predose and did not have the corresponding symptoms at Week 8 judged by investigators.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    2
    6
    4
    7
    9
    Units: Participants
    2
    5
    4
    2
    6
    No statistical analyses for this end point

    Primary: Disappearance of upper abdominal discomfort at Week 8 by investigators

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    End point title
    Disappearance of upper abdominal discomfort at Week 8 by investigators [12]
    End point description
    The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of upper abdominal discomfort were defined as those who had an upper abdominal discomfort at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    3
    6
    5
    7
    6
    Units: Participants
    3
    5
    4
    4
    3
    No statistical analyses for this end point

    Primary: Disappearance of regurgitation at Week 8 by investigators

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    End point title
    Disappearance of regurgitation at Week 8 by investigators [13]
    End point description
    The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of regurgitation were defined as those who had a regurgitation at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    4
    1
    5
    1
    3
    Units: Participants
    3
    0
    3
    1
    3
    No statistical analyses for this end point

    Primary: Aggravation of heartburn at Week 8 by investigators

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    End point title
    Aggravation of heartburn at Week 8 by investigators [14]
    End point description
    The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of heartburn were defined as those who had no heartburn at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    7
    8
    9
    7
    7
    Units: Participants
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Aggravation of epigastric pain at Week 8 by investigators

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    End point title
    Aggravation of epigastric pain at Week 8 by investigators [15]
    End point description
    The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of epigastric pain were defined as those who had no epigastric pain at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    7
    4
    5
    2
    1
    Units: Participants
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Aggravation of upper abdominal discomfort at Week 8 by investigators

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    End point title
    Aggravation of upper abdominal discomfort at Week 8 by investigators [16]
    End point description
    The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of upper abdominal discomfort were defined as those who had no upper abdominal discomfort at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    6
    4
    4
    2
    4
    Units: Participants
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Aggravation of regurgitation at Week 8 by investigators

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    End point title
    Aggravation of regurgitation at Week 8 by investigators [17]
    End point description
    The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of regurgitation were defined as those who had no regurgitation at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study is to evaluate the safety and efficacy of D961H 10 mg and 20 mg for Japanese pediatric patients with upper gastrointestinal disease, not to compare the two dosages of D961H 10 mg and 20 mg. Therefore, no formal statistical analyses were performed and only descriptive statistical analyses were used. No appropriate information for the statistical analyses sections was available in this study.
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    5
    9
    4
    8
    7
    Units: Participants
    0
    0
    1
    0
    1
    No statistical analyses for this end point

    Secondary: AUCtau of esomeprazole after at least 5 days of repeated dose

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    End point title
    AUCtau of esomeprazole after at least 5 days of repeated dose
    End point description
    End point type
    Secondary
    End point timeframe
    After at least 5 days of repeated dose
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    7
    9
    10
    9
    10
    Units: μmol*h/L
        arithmetic mean (standard deviation)
    7.04 ± 3.05
    3.52 ± 2.35
    11.05 ± 5.11
    2.38 ± 1.74
    5.82 ± 1.85
    No statistical analyses for this end point

    Secondary: AUC0-t of esomeprazole after at least 5 days of repeated dose

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    End point title
    AUC0-t of esomeprazole after at least 5 days of repeated dose
    End point description
    End point type
    Secondary
    End point timeframe
    After at least 5 days of repeated dose
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    9
    10
    10
    9
    10
    Units: μmol*h/L
        arithmetic mean (standard deviation)
    5.53 ± 3.69
    3.09 ± 2.34
    10.41 ± 4.55
    1.99 ± 1.3
    5.45 ± 1.78
    No statistical analyses for this end point

    Secondary: Cmax of esomeprazole after at least 5 days of repeated dose

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    End point title
    Cmax of esomeprazole after at least 5 days of repeated dose
    End point description
    End point type
    Secondary
    End point timeframe
    After at least 5 days of repeated dose
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    9
    10
    10
    9
    10
    Units: μmol/L
        arithmetic mean (standard deviation)
    3.42 ± 2.09
    2.09 ± 1.53
    5.91 ± 2.19
    1.09 ± 0.57
    3.13 ± 1.36
    No statistical analyses for this end point

    Secondary: tmax of esomeprazole after at least 5 days of repeated dose

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    End point title
    tmax of esomeprazole after at least 5 days of repeated dose
    End point description
    End point type
    Secondary
    End point timeframe
    After at least 5 days of repeated dose
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    9
    10
    10
    9
    10
    Units: hour
        median (full range (min-max))
    1.58 (1.03 to 5.92)
    1.52 (0.92 to 6)
    1.47 (0.93 to 1.52)
    1.57 (0.93 to 2.95)
    1.75 (0.95 to 3)
    No statistical analyses for this end point

    Secondary: thalf of esomeprazole after at least 5 days of repeated dose

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    End point title
    thalf of esomeprazole after at least 5 days of repeated dose
    End point description
    End point type
    Secondary
    End point timeframe
    After at least 5 days of repeated dose
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    7
    9
    10
    9
    10
    Units: hour
        arithmetic mean (standard deviation)
    0.8 ± 0.18
    0.97 ± 0.55
    1.08 ± 0.44
    1.37 ± 0.88
    1.06 ± 0.25
    No statistical analyses for this end point

    Secondary: CL/F (Apparent total clearance) of esomeprazole after at least 5 days of repeated dose

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    End point title
    CL/F (Apparent total clearance) of esomeprazole after at least 5 days of repeated dose
    End point description
    End point type
    Secondary
    End point timeframe
    After at least 5 days of repeated dose
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    7
    9
    10
    9
    10
    Units: L/h
        arithmetic mean (standard deviation)
    4.74 ± 1.92
    12.44 ± 8.9
    6.44 ± 3.37
    23.33 ± 24.93
    10.94 ± 3.64
    No statistical analyses for this end point

    Secondary: Vz/F (Apparent volume of distribution) of esomeprazole after at least 5 days of repeated dose

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    End point title
    Vz/F (Apparent volume of distribution) of esomeprazole after at least 5 days of repeated dose
    End point description
    End point type
    Secondary
    End point timeframe
    After at least 5 days of repeated dose
    End point values
    Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    7
    9
    10
    9
    10
    Units: Liter
        arithmetic mean (standard deviation)
    5.1 ± 1.24
    16.56 ± 16.21
    9.21 ± 4
    44.73 ± 72.03
    15.9 ± 4.42
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other advers events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
    Adverse event reporting additional description
    Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other advers events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Group 1
    Reporting group description
    D961H sachet 10 mg Age: 1-11 years and Weight <20 kg

    Reporting group title
    Group 3
    Reporting group description
    D961H capsule 20 mg Age: 1-11 years and Weight: >=20 kg

    Reporting group title
    Group 2
    Reporting group description
    D961H capsule 10 mg Age: 1-11 years and Weight >=20 kg

    Reporting group title
    Group 4
    Reporting group description
    D961H capsule 10 mg Age: 12-14 years and Weight: >=20 kg

    Reporting group title
    Group 5
    Reporting group description
    D961H capsule 20 mg Age: 12-14 years and Weight: >=20 kg

    Serious adverse events
    Group 1 Group 3 Group 2 Group 4 Group 5
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Group 1 Group 3 Group 2 Group 4 Group 5
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 10 (80.00%)
    5 / 10 (50.00%)
    8 / 10 (80.00%)
    5 / 10 (50.00%)
    6 / 10 (60.00%)
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    2
    0
    2
    Eye disorders
    Hordeolum
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    0
    1
    Anal fissure
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dental caries
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    2
    0
    0
    1
    Gingival pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    1
    0
    3
    Stomatitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Photosensitivity reaction
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    0
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Influenza
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Mumps
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 10 (20.00%)
    4 / 10 (40.00%)
    1 / 10 (10.00%)
    3 / 10 (30.00%)
         occurrences all number
    1
    3
    7
    1
    3
    Otitis media
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Streptococcal infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    Varicella
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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