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    Clinical Trial Results:
    A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Multiple Doses of Esomeprazole Magnesium in a Pediatric Population of 1 to 11 Year olds with Gastroesophageal Reflux Disease (GERD) or Symptoms of GERD

    Summary
    EudraCT number
    		 2012-001157-97
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    10 Mar 2005

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

    Trial information

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    Trial identification
    Sponsor protocol code
    D9614C00099
    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
    10 Mar 2005
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Mar 2005
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Mar 2005
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the area under the curve (AUC) of esomeprazole after multiple oral doses of 5 mg, 10 mg, and 20 mg esomeprazole magnesium in 1 to 11 year olds, inclusive with GERD or symptoms of GERD.
    Protection of trial subjects
    The study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and that are consistent with ICH/Good Clinical Practice and applicable regulatory requirements and the AstraZeneca policy on Bioethics. The study was approved by the independent Institutional Review Board/Research Ethics Committee, Coast IRB, 901 Calle Amanecer, Suite 260, San Clemente, CA 92673. Informed consent was obtained from all subjects prior to initiation of the study. Subjects could be discontinued from study treatment and assessments at any time, voluntary by subject or as judged by the investigator or AstraZeneca.
    Background therapy
    		 The target subject population was male and female children, aged 1 to 11 years inclusive, who suffered from GERD or symptoms of GERD and were candidates for acid suppression therapy. Eligible subjects had to be able to tolerate discontinuation of their PPI therapy for 7 days and/or H2RA therapy for 3 days prior to the first dose of study drug.
    Evidence for comparator
    		 No comparator group.
    Actual start date of recruitment
    22 Mar 2004
    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: 31
    Worldwide total number of subjects
    31
    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)
    29
    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: 22 March 2004 Last subject completed: 31 July 2004

    Pre-assignment
    Screening details
    		 34 subjects were screened. Thirty-one (31) of these subjects were randomized and 3 failed screening. Of the 3 screen failures, 1 could not participate due to scheduling conflicts and 2 had abnormal lab values.

    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 5 mg (Age 1-5 yr)
    Arm description
    		 Esomeprazole 5 mg (Age 1-5 yr)
    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
    5 mg od orally

    Arm title
    		 Esomeprazole 10 mg (Age 1-5 yr)
    Arm description
    		 Esomeprazole 10 mg (Age 1-5 yr)
    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
    10 mg od orally

    Arm title
    		 Esomeprazole 10 mg (6-11 years)
    Arm description
    		 Esomeprazole 10 mg (6-11 years)
    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
    10 mg od orally

    Arm title
    		 Esomeprazole 20 mg (6-11 yr)
    Arm description
    		 Esomeprazole 20 mg (6-11 yr)
    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 orally

    Number of subjects in period 1
    		Esomeprazole 5 mg (Age 1-5 yr) Esomeprazole 10 mg (Age 1-5 yr) Esomeprazole 10 mg (6-11 years) Esomeprazole 20 mg (6-11 yr)
    Started
    9
    9
    7
    6
    Completed
    6
    8
    7
    6
    Not completed
    3
    1
    0
    0
         Consent withdrawn by subject
    2
    1
    -
    -
         Refused to take study medication on Day 1
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Esomeprazole 5 mg (Age 1-5 yr)
    Reporting group description
    		 Esomeprazole 5 mg (Age 1-5 yr)

    Reporting group title
    Esomeprazole 10 mg (Age 1-5 yr)
    Reporting group description
    		 Esomeprazole 10 mg (Age 1-5 yr)

    Reporting group title
    Esomeprazole 10 mg (6-11 years)
    Reporting group description
    		 Esomeprazole 10 mg (6-11 years)

    Reporting group title
    Esomeprazole 20 mg (6-11 yr)
    Reporting group description
    		 Esomeprazole 20 mg (6-11 yr)

    Reporting group values
    		 Esomeprazole 5 mg (Age 1-5 yr) Esomeprazole 10 mg (Age 1-5 yr) Esomeprazole 10 mg (6-11 years) Esomeprazole 20 mg (6-11 yr) Total
    Number of subjects
    		 9 9 7 6 31
    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)
    		 0 2 0 0 2
        Children (2-11 years)
    		 9 7 7 6 29
        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
    Age (years)
    Units: years
        arithmetic mean (full range (min-max))
    		 3.8 (2 to 5) 2.3 (1 to 4) 8.4 (6 to 11) 7.8 (6 to 11) -
    Gender Categorical
    Units: Subjects
        Female
    		 6 3 2 3 14
        Male
    		 3 6 5 3 17
    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
    31
    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)
    2
        Children (2-11 years)
    29
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age Continuous
    Age (years)
    Units: years
        arithmetic mean (full range (min-max))
    5.2 (1 to 11)
    Gender Categorical
    Units: Subjects
        Female
    14
        Male
    17

    End points

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    End points reporting groups
    Reporting group title
    Esomeprazole 5 mg (Age 1-5 yr)
    Reporting group description
    		 Esomeprazole 5 mg (Age 1-5 yr)

    Reporting group title
    Esomeprazole 10 mg (Age 1-5 yr)
    Reporting group description
    		 Esomeprazole 10 mg (Age 1-5 yr)

    Reporting group title
    Esomeprazole 10 mg (6-11 years)
    Reporting group description
    		 Esomeprazole 10 mg (6-11 years)

    Reporting group title
    Esomeprazole 20 mg (6-11 yr)
    Reporting group description
    		 Esomeprazole 20 mg (6-11 yr)

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

    Primary: Primary PK parameter AUC

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    End point title
    		 Primary PK parameter AUC [1]
    End point description
    AUC after repeated doses
    End point type
    Primary
    End point timeframe
    after repetaed doses (5 days)
    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 analyses were specified for this primary end point
    End point values
    		 Esomeprazole 5 mg (Age 1-5 yr) Esomeprazole 10 mg (Age 1-5 yr) Esomeprazole 10 mg (6-11 years) Esomeprazole 20 mg (6-11 yr)
    Number of subjects analysed
    5 [2]
    8 [3]
    7 [4]
    6 [5]
    Units: micromol*h/L
        geometric mean (standard deviation)
    0.74 ( 0.36 )
    4.83 ( 2.56 )
    3.7 ( 2.05 )
    6.28 ( 2.71 )
    Notes
    [2] - number of subjects evaluated for AUC
    [3] - number of subjects evaluated for AUC
    [4] - number of subjects evaluated for AUC
    [5] - number of subjects evaluated for AUC
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment (5 days)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    6.0
    Reporting groups
    Reporting group title
    Esomeprazole 5 mg (Age 1-5 yr)
    Reporting group description
    		 Esomeprazole 5 mg (Age 1-5 yr)

    Reporting group title
    Esomeprazole 10 mg (Age 1-5 yr)
    Reporting group description
    		 Esomeprazole 10 mg (Age 1-5 yr)

    Reporting group title
    Esomeprazole 10 mg (6-11 years)
    Reporting group description
    		 Esomeprazole 10 mg (6-11 years)

    Reporting group title
    Esomeprazole 20 mg (6-11 yr)
    Reporting group description
    		 Esomeprazole 20 mg (6-11 yr)

    Serious adverse events
    		 Esomeprazole 5 mg (Age 1-5 yr) Esomeprazole 10 mg (Age 1-5 yr) Esomeprazole 10 mg (6-11 years) Esomeprazole 20 mg (6-11 yr)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Esomeprazole 5 mg (Age 1-5 yr) Esomeprazole 10 mg (Age 1-5 yr) Esomeprazole 10 mg (6-11 years) Esomeprazole 20 mg (6-11 yr)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 9 (22.22%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Gastrointestinal disorders
    Faeces discoloured
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    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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