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    Clinical Trial Results:
    A Phase III, Multicenter, Randomized, Double-blind, Parallel-group Study to Evaluate the Safety of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years, Inclusive

    Summary
    EudraCT number
    		 2012-001136-61
    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
    16 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D9614C00098
    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, 1 302-885-5514,
    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 this study was to evaluate the safety and tolerability of once daily treatment with esomeprazole in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed 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 ICH/Good Clinical Practice and applicable regulatory requirements and the AstraZeneca policy on Bioethics. The final Clinical Study Protocol (CSP), including the final version of the Informed Consent Form and all advertising used to recruit patients, had to be approved by an Institutional Review Board (IRB) before enrollment of any patient into the study.All patients (and their parents/guardians) were provided with all the information necessary to make an informed decision about their participation in the study, including the nature and intended purpose of the study, possible benefits and possible risks. All information in the informed consent form was provided in language understandable to the patients and their parents/guardians. The patient’s parent/guardian’s signed and dated informed consent as well as the patient’s signed and dated assent were obtained before conducting any procedure specifically for the study. If the patient or patient’s parents/guardians could not read, the informed consent form (or assent) was signed and dated by an impartial witness. The person who discussed the informed consent information with the patient also signed and dated the form.Patients could be discontinued from study treatment and assessments at any time, voluntary by the patient who was free to discontinue at anay time, or at the discretion of the investigator(s)
    Background therapy
    		 PPI use within 14 days prior to randomization (Visit 2), including over-the-counter (OTC) PRILOSEC® (AstraZeneca LP) was exclusion criteria, as was any prescription or OTC treatment use for symptoms of GERD, such as H2RA or prokinetics, within 3 days (72 hours) prior to randomization (Visit 2). Antacids were allowed, except for those containing bismuth.
    Evidence for comparator
    		 No comparator group
    Actual start date of recruitment
    20 Feb 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
    France: 5
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Canada: 21
    Country: Number of subjects enrolled
    United States: 122
    Worldwide total number of subjects
    149
    EEA total number of subjects
    6
    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)
    149
    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 patient enrolled: 20 February 2004 Last patient completed: 04 May 2005

    Pre-assignment
    Screening details
    		 Out of 157 patients screened for this study, 8 patients failed to be eligible and never received study medication.

    Pre-assignment period milestones
    Number of subjects started
    		 149
    Number of subjects completed
    		 149

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Carer, Data analyst, Assessor, Subject
    Blinding implementation details
    Double-blind

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Esomeprazole 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 orally

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

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

    Number of subjects in period 1
    		Esomeprazole 20 mg Esomeprazole 40 mg
    Started
    76
    73
    Completed
    60
    67
    Not completed
    16
    6
         Consent withdrawn by subject
    4
    1
         Adverse event, non-fatal
    5
    1
         Lost to follow-up
    1
    3
         Lack of efficacy
    2
    -
         Not eligible, developed discont. crit, 2 not spec.
    4
    1

    Baseline characteristics

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

    Reporting group title
    Esomeprazole 40 mg
    Reporting group description
    		 Esomeprazole magnesium 40 mg

    Reporting group values
    		 Esomeprazole 20 mg Esomeprazole 40 mg Total
    Number of subjects
    		 76 73 149
    Age Categorical
    Age years
    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)
    		 76 73 149
        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
        median (full range (min-max))
    		 14 (12 to 17) 14 (12 to 17) -
    Gender Categorical
    Units: Subjects
        Female
    		 47 42 89
        Male
    		 29 31 60
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT

    Subject analysis sets values
    		 ITT
    Number of subjects
    149
    Age Categorical
    Age years
    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)
    149
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age Continuous
    Age (years)
    Units: years
        median (full range (min-max))
    14 (12 to 17)
    Gender Categorical
    Units: Subjects
        Female
    89
        Male
    60

    End points

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

    Reporting group title
    Esomeprazole 40 mg
    Reporting group description
    		 Esomeprazole magnesium 40 mg

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT

    Primary: Number of patients whose Physician Global Assessment score improved from baseline at their final visit (ITT population)

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    End point title
    		 Number of patients whose Physician Global Assessment score improved from baseline at their final visit (ITT population) [1]
    End point description
    Number of patients whose Physician's Globle Assessment score improved from baseline
    End point type
    Primary
    End point timeframe
    From baseline to final Visit
    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: Only Discriptive statistics are provided for the endpoints.
    End point values
    		 Esomeprazole 20 mg Esomeprazole 40 mg ITT
    Number of subjects analysed
    76
    73
    149
    Units: Number of subjects
    55
    55
    110
    No statistical analyses for this end point

    Secondary: Heartburn Symptom - average change from baseline at final week

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    End point title
    		 Heartburn Symptom - average change from baseline at final week
    End point description
    symptoms were rated on a 4-point scale as follows: 0=none; 1=mild; 2=moderate; 3=severe.
    End point type
    Secondary
    End point timeframe
    Baseline to final week
    End point values
    		 Esomeprazole 20 mg Esomeprazole 40 mg ITT
    Number of subjects analysed
    73 [2]
    72 [3]
    145 [4]
    Units: Change in average score
        arithmetic mean (standard deviation)
    -0.72 ± 0.97
    -0.71 ± 0.92
    -0.72 ± 0.95
    Notes
    [2] - All patients who had heartburn symptoms at baseline
    [3] - All patients who had heartburn symptoms at baseline
    [4] - All patients who had heartburn symptoms at baseline
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During treatment (8weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8.0
    Reporting groups
    Reporting group title
    Esomeprazole 40 mg
    Reporting group description
    		 Esomeprazole magnesium 40 mg

    Reporting group title
    Esomeprazole 20 mg
    Reporting group description
    		 Esomeprazole magnesium 20 mg

    Serious adverse events
    		 Esomeprazole 40 mg Esomeprazole 20 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (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 40 mg Esomeprazole 20 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    57 / 73 (78.08%)
    56 / 75 (74.67%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 73 (20.55%)
    12 / 75 (16.00%)
         occurrences all number
    57
    56
    General disorders and administration site conditions
    pyrexia
         subjects affected / exposed
    2 / 73 (2.74%)
    5 / 75 (6.67%)
         occurrences all number
    57
    56
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    9 / 73 (12.33%)
    9 / 75 (12.00%)
         occurrences all number
    57
    56
    Diarrhoea
         subjects affected / exposed
    8 / 73 (10.96%)
    6 / 75 (8.00%)
         occurrences all number
    57
    56
    Vomiting
         subjects affected / exposed
    7 / 73 (9.59%)
    5 / 75 (6.67%)
         occurrences all number
    57
    56
    Nausea
         subjects affected / exposed
    4 / 73 (5.48%)
    6 / 75 (8.00%)
         occurrences all number
    57
    56
    constipation
         subjects affected / exposed
    4 / 73 (5.48%)
    2 / 75 (2.67%)
         occurrences all number
    57
    56
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 73 (6.85%)
    6 / 75 (8.00%)
         occurrences all number
    57
    56
    pharyngolaryngeal pain
         subjects affected / exposed
    9 / 73 (12.33%)
    1 / 75 (1.33%)
         occurrences all number
    57
    56
    Nasal congestion
         subjects affected / exposed
    1 / 73 (1.37%)
    4 / 75 (5.33%)
         occurrences all number
    57
    56
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 73 (12.33%)
    9 / 75 (12.00%)
         occurrences all number
    57
    56
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 73 (5.48%)
    9 / 75 (12.00%)
         occurrences all number
    57
    56
    sinusitis
         subjects affected / exposed
    4 / 73 (5.48%)
    3 / 75 (4.00%)
         occurrences all number
    57
    56

    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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