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    Clinical Trial Results:
    A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Esomeprazole Magnesium 20 mg and 40 mg in a Pediatric Population of 12 to 17 Year-Olds with Gastroesophageal Reflux Disease (GERD) or Symptoms of GERD

    Summary
    EudraCT number
    		 2012-001158-25
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Jul 2004

    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
    D9614C00094
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca Pharmaceuticals
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, MD, United States, 20878
    Public contact
    AZ Clinical Trial Transparency group, AstraZeneca R&D, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    June Zhao, MD, AstraZeneca Pharmaceuticals, www.June.Zhao@astrazeneca.com
    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
    15 Jul 2004
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jul 2004
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2004
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine AUC after single and repeated (multiple) oral doses of 20 mg and 40 mg esomeprazole magnesium in 12- to 17-year-olds inclusive with GERD or symptoms of GERD.
    Protection of trial subjects
    The 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)/Research Ethics Committee, the Arkansas Research Human Volunteers Research Committee. Informed consent was obtained from all subjects’ parent/guardian with assent from all subjects prior to Screening. Subjects were at any time free to discontinue his/her participation in the study without prejudice to further treatment
    Background therapy
    		 Concurrent therapy with PPIs and H2RAs was not permitted within 7 days prior to Day 1 until discharge from the CRC on Day 8. Any medication, which was considered necessary for the subject’s safety and well-being, was allowed at the discretion of the investigator
    Evidence for comparator
    		 No comparator group
    Actual start date of recruitment
    08 Sep 2003
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    28
    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: 08 September 2003 Last subject completed: 13 October 2003

    Pre-assignment
    Screening details
    		 38 subjects were screened and 28 subjects were enrolled and randomised

    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
    		 esomeprazole magnesium 20 mg
    Arm description
    		 esomeprazole magnesium 20 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    esomeprazole magnesium
    Investigational medicinal product code
    Other name
    NEXIUM
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg od

    Arm title
    		 esomeprazole magnesium 40 mg
    Arm description
    		 esomeprazole magnesium 40 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    esomeprazole magnesium
    Investigational medicinal product code
    Other name
    NEXIUM
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg od

    Number of subjects in period 1
    		esomeprazole magnesium 20 mg esomeprazole magnesium 40 mg
    Started
    14
    14
    Completed
    14
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    esomeprazole magnesium 20 mg
    Reporting group description
    		 esomeprazole magnesium 20 mg

    Reporting group title
    esomeprazole magnesium 40 mg
    Reporting group description
    		 esomeprazole magnesium 40 mg

    Reporting group values
    		 esomeprazole magnesium 20 mg esomeprazole magnesium 40 mg Total
    Number of subjects
    		 14 14 28
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 14 14 28
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Age (years)
    Units: years
        arithmetic mean (standard deviation)
    		 13.9 ( 1.98 ) 14.7 ( 1.68 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 6 7 13
        Male
    		 8 7 15
    Subject analysis sets

    Subject analysis set title
    Full data set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Full data set

    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)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    28
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age Continuous
    Age (years)
    Units: years
        arithmetic mean (standard deviation)
    14.3 ( 1.85 )
    Gender Categorical
    Units: Subjects
        Female
    13
        Male
    15

    End points

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    End points reporting groups
    Reporting group title
    esomeprazole magnesium 20 mg
    Reporting group description
    		 esomeprazole magnesium 20 mg

    Reporting group title
    esomeprazole magnesium 40 mg
    Reporting group description
    		 esomeprazole magnesium 40 mg

    Subject analysis set title
    Full data set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Full data set

    Primary: AUC single dose

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    End point title
    		 AUC single dose [1]
    End point description
    AUC (umol*h/L)
    End point type
    Primary
    End point timeframe
    After single dose
    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: There is no statistical analyses specified for the pharmacokinetic results because there was no hypothesis being tested. Discriptive statistis are only presented
    End point values
    		 esomeprazole magnesium 20 mg esomeprazole magnesium 40 mg
    Number of subjects analysed
    11
    13
    Units: umol*h/L
        geometric mean (confidence interval 95%)
    1.58 (1.07 to 2.32)
    5.88 (3.94 to 7.88)
    No statistical analyses for this end point

    Primary: AUC after repeated dosing

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    End point title
    		 AUC after repeated dosing [2]
    End point description
    AUC after repeated dosin
    End point type
    Primary
    End point timeframe
    After repeated dosing
    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: There is no statistical analyses specified for the pharmacokinetic results because there was no hypothesis being tested. Discriptive statistis are only presented
    End point values
    		 esomeprazole magnesium 20 mg esomeprazole magnesium 40 mg
    Number of subjects analysed
    12
    12
    Units: umol*h/L
        geometric mean (confidence interval 95%)
    3.65 (2.63 to 5.05)
    13.86 (10.85 to 17.7)
    No statistical analyses for this end point

    Secondary: AUC(0-t) after single dose

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    End point title
    		 AUC(0-t) after single dose
    End point description
    AUC(0-t) (umol*h/L) after single dosing
    End point type
    Secondary
    End point timeframe
    After single dose
    End point values
    		 esomeprazole magnesium 20 mg esomeprazole magnesium 40 mg
    Number of subjects analysed
    14
    14
    Units: umol*h/L
        geometric mean (confidence interval 95%)
    0.83 (0.37 to 1.84)
    4.89 (3.43 to 6.97)
    No statistical analyses for this end point

    Secondary: AUC(0-t) after repeated dosing

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    End point title
    		 AUC(0-t) after repeated dosing
    End point description
    AUC(0-t) (umol*h/L) after repeated dosing
    End point type
    Secondary
    End point timeframe
    After repeated dosing
    End point values
    		 esomeprazole magnesium 20 mg esomeprazole magnesium 40 mg
    Number of subjects analysed
    14
    14
    Units: umol*h/L
        geometric mean (confidence interval 95%)
    2.47 (1.37 to 4.46)
    11.51 (8.87 to 14.94)
    No statistical analyses for this end point

    Secondary: Cmax after single dosing

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    End point title
    		 Cmax after single dosing
    End point description
    Cmax (umol/L) after single dosing
    End point type
    Secondary
    End point timeframe
    After single dosing
    End point values
    		 esomeprazole magnesium 20 mg esomeprazole magnesium 40 mg
    Number of subjects analysed
    14
    14
    Units: umol/L
        geometric mean (confidence interval 95%)
    0.67 (0.34 to 1.84)
    2.78 (1.97 to 3.91)
    No statistical analyses for this end point

    Secondary: Cmax after repeated dosing

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    End point title
    		 Cmax after repeated dosing
    End point description
    Cmax (umol/L) after repeated dosing
    End point type
    Secondary
    End point timeframe
    After repeated dosing
    End point values
    		 esomeprazole magnesium 20 mg esomeprazole magnesium 40 mg
    Number of subjects analysed
    14
    14
    Units: umol/L
        geometric mean (confidence interval 95%)
    1.45 (0.83 to 2.53)
    5.13 (4 to 6.57)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During enrollement/randomised treatment (8 days)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    6.0
    Reporting groups
    Reporting group title
    esomeprazole magnesium 40 mg
    Reporting group description
    		 esomeprazole magnesium 40 mg

    Reporting group title
    esomeprazole magnesium 20 mg
    Reporting group description
    		 esomeprazole magnesium 20 mg

    Serious adverse events
    		 esomeprazole magnesium 40 mg esomeprazole magnesium 20 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 esomeprazole magnesium 40 mg esomeprazole magnesium 20 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 14 (7.14%)
    3 / 14 (21.43%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    tooth ache
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    vomiting
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Joint swelling
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jul 2003
    Multiple items

    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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