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    Clinical Trial Results:
    A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Esomeprazole Magnesium in Pediatric Patients 1 to 11 Years-Old Inclusive with Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)

    Summary
    EudraCT number
    		 2012-001156-19
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 Sep 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2017
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D9614C00007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca LP
    Sponsor organisation address
    1800 Concord Pike, Wilmington, Delaware , United States, 19850
    Public contact
    AZ Clinical Trial Transparency group, AstraZeneca R&D, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Marta Illueca, MD, FAAP, AstraZeneca LP, 1 302-885-1487,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000331-PIP01-08
    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
    19 Sep 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Sep 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Sep 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to determine the area under the plasma concentration time curve (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg, or 20 mg esomeprazole in pediatric patients 1 to 11 years old, inclusive, with endoscopically proven GERD.
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) and applicable regulatory requirements and the AstraZeneca policy on Bioethics. The study was approved by the independent Institutional Review Board (IRB)/Independent Ethics Committee (IEC). Signed, written informed consent from patient’s parent/guardian with assent from the patient, if appropriate were obtained before any study procedures.
    Background therapy
    		 Other medication considered necessary for the patient's safety and well being could be given at the discretion of the investigator(s). Patients were not allowed to take any prescription or OTC PPIs beginning from 7 days before and H2RAs beginning from 3 days before randomization through completion of study procedures on Day 1. PPIs and H2RAs were resumed after discharge from the CRC at the discretion of the investigator. Patients were not allowed to take OTC antacids from 24 hours before randomization through completion of study procedures on Day 1. Resumption of treatment with antacids was at the discretion of the investigator.
    Evidence for comparator
    		 No comparator group
    Actual start date of recruitment
    14 Aug 2006
    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
    United States: 28
    Worldwide total number of subjects
    28
    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)
    5
    Children (2-11 years)
    23
    Adolescents (12-17 years)
    0
    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
    		 First subject enrolled: 14 August 2006 Last subject completed: 08 May 2008

    Pre-assignment
    Screening details
    		 35 patients were screened and 28 subjects were eligible for study

    Pre-assignment period milestones
    Number of subjects started
    		 28
    Number of subjects completed
    		 28

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open label

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Subjects 8 to<20 kg, esomeprazole 5 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Esomeprazole
    Investigational medicinal product code
    Other name
    NEXIUM
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg single oral dose

    Arm title
    		 Group B
    Arm description
    		 BW 8 to <20 kg, esomeprazole 10 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Esomeprazole
    Investigational medicinal product code
    Other name
    NEXIUM
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg single dose orally

    Arm title
    		 Group C
    Arm description
    		 BW > 20 kg, esomeprazole 10 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Esomeprazole
    Investigational medicinal product code
    Other name
    NEXIUM
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg single dose orally

    Arm title
    		 Group D
    Arm description
    		 BW > 20kg, esomeprazole 20 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Esomeprazole
    Investigational medicinal product code
    Other name
    NEXIUM
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg single dose orally

    Number of subjects in period 1
    		Group A Group B Group C Group D
    Started
    7
    7
    6
    8
    Completed
    7
    7
    6
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Subjects 8 to<20 kg, esomeprazole 5 mg

    Reporting group title
    Group B
    Reporting group description
    		 BW 8 to <20 kg, esomeprazole 10 mg

    Reporting group title
    Group C
    Reporting group description
    		 BW > 20 kg, esomeprazole 10 mg

    Reporting group title
    Group D
    Reporting group description
    		 BW > 20kg, esomeprazole 20 mg

    Reporting group values
    		 Group A Group B Group C Group D Total
    Number of subjects
    		 7 7 6 8 28
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 2 3 0 0 5
        Children (2-11 years)
    		 5 4 6 8 23
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Full data set, total n=28
    Units: years
        arithmetic mean (full range (min-max))
    		 3.14 (1 to 5) 3 (1 to 6) 8 (6 to 10) 8.5 (5 to 11) -
    Gender Categorical
    Units: Subjects
        Female
    		 2 2 2 6 12
        Male
    		 5 5 4 2 16
    Subject analysis sets

    Subject analysis set title
    Full data set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full data set total (n=28)

    Subject analysis sets values
    		 Full data set
    Number of subjects
    28
    Age Categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    5
        Children (2-11 years)
    23
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age Continuous
    Full data set, total n=28
    Units: years
        arithmetic mean (full range (min-max))
    5.68 (1 to 11)
    Gender Categorical
    Units: Subjects
        Female
    12
        Male
    16

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Subjects 8 to<20 kg, esomeprazole 5 mg

    Reporting group title
    Group B
    Reporting group description
    		 BW 8 to <20 kg, esomeprazole 10 mg

    Reporting group title
    Group C
    Reporting group description
    		 BW > 20 kg, esomeprazole 10 mg

    Reporting group title
    Group D
    Reporting group description
    		 BW > 20kg, esomeprazole 20 mg

    Subject analysis set title
    Full data set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full data set total (n=28)

    Primary: AUC

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    End point title
    		 AUC [1]
    End point description
    Area under the esomeprazole plasma concentration-time curve
    End point type
    Primary
    End point timeframe
    1 day
    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: Descriptive - no statistical anlysis
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    6 [2]
    7
    5 [3]
    7 [4]
    Units: µmolh/L
        geometric mean (full range (min-max))
    0.73 (0.35 to 3.16)
    1.32 (0.67 to 3.12)
    0.69 (0.35 to 1.37)
    3.06 (1.04 to 9.96)
    Notes
    [2] - Insufficient no. measurable plasma concentrations in 1 patient to determine AUC
    [3] - Insufficient no. measurable plasma concentrations in 1 patient to determine AUC
    [4] - Insufficient no. measurable plasma concentrations in 1 patient to determine AUC
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During single dose treatment through 7-14 days postdose
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    Not known
    Reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Subjects 8 to<20 kg, esomeprazole 5 mg

    Reporting group title
    Group B
    Reporting group description
    		 BW 8 to <20 kg, esomeprazole 10 mg

    Reporting group title
    Group C
    Reporting group description
    		 BW > 20 kg, esomeprazole 10 mg

    Reporting group title
    Group D
    Reporting group description
    		 BW > 20kg, esomeprazole 20 mg

    Serious adverse events
    		 Group A Group B Group C Group D
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group A Group B Group C Group D
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 7 (28.57%)
    5 / 7 (71.43%)
    3 / 6 (50.00%)
    3 / 8 (37.50%)
    Infections and infestations
    Ear infection
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 7 (28.57%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    0
    sinusitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Mar 2007
    Patients who had an endoscopy within 42 days of enrollment were not required to have an endoscopy at the screening visit.
    18 Sep 2007
    Interim analysis added, change in requirement for endoscopy in smaller children, BW criteria extended

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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