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    Clinical Trial Results:
    An Open Single-centre Study on the Pharmacokinetics and Pharmacodynamics of Esomeprazole After Once Daily Oral Administration for 7 Days in Preterm Infants and Neonates

    Summary
    EudraCT number
    2012-001160-29
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    10 Jan 2007

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

    Trial information

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    Trial identification
    Sponsor protocol code
    SH-NEC-0002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca R&D
    Sponsor organisation address
    Pepparedsled 1, Mölndal, Sweden,
    Public contact
    AZ Clinical Trial Transparency group, AstraZeneca R&D, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Per Lundborg, MD, PhD , AstraZeneca R&D Mölndal, 46 317761000,
    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 Jan 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jan 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the pharmacokinetics of esomeprazole and its effect on intragastric pH in preterm infants and neonates.
    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. Consideration has been given to the International Conference on Harmonisation (ICH) guideline CPMP/ICH/2711/99 (Note for clinical investigation of medicinal products in the pediatric population) when developing the study.The study was approved by the Independent Research Ethics Committee (IEC) of the Women’s and Children’s Hospital, 72 King William Road, North Adelaide, South Australia 5006 Since all subjects in this study were preterm infants or neonates, informed consent could not be obtained from the subjects themselves. Therefore, the principal investigator ensured that the parent(s) or guardian(s) was given full and adequate oral and written information about the nature, purpose, possible risks and benefits of the study. Parents/guardians were also notified that they were free to withdraw their child from participation in the study at any time. The parent(s)/guardian(s) was given the opportunity to ask questions, and was given time for consideration. The parent’s/guardian’s signed informed consent was obtained before any study specific procedure was conducted. Subjects could be withdrawn from study treatment and assessments at any time at the discretion of the investigator.
    Background therapy
    The subject population comprised in- and outpatient preterm infants or neonates up to 1 month of age with symptoms of GERD and diagnosis confirmed by pH-monitoring. Medication considered necessary for the subject’s safety and well-being was to be given at the discretion of the investigator. Use of any pharmacological antireflux therapy within 72 hours prior to the diagnostic baseline pH impedance monitoring was exclusion criteria. Antacids (egMylanta) or food thickeners could be used +/- 1 hour of the administration of investigational product .
    Evidence for comparator
    No comparator group
    Actual start date of recruitment
    02 Jun 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
    Australia: 26
    Worldwide total number of subjects
    26
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    19
    Newborns (0-27 days)
    7
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    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 patient enrolled: 2 June 2004 Last patient completed: 8 March 2006

    Pre-assignment
    Screening details
    38 subjects were screened and 26 were eligible for the study.

    Pre-assignment period milestones
    Number of subjects started
    26
    Number of subjects completed
    26

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

    Arms
    Arm title
    Esomeprazole treatment
    Arm description
    Esomeprazole 0.5 mg/kg
    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
    0.5 mg/kg od orally for 1 week

    Number of subjects in period 1
    Esomeprazole treatment
    Started
    26
    Completed
    25
    Not completed
    1
         Consent withdrawn by subject
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    Esomeprazole

    Reporting group values
    Treatment period Total
    Number of subjects
    26 26
    Age Categorical
    Units: Subjects
    Age Continuous
    Gestational age at birth
    Units: weeks
        arithmetic mean (full range (min-max))
    32.1 (23 to 41) -
    Gender Categorical
    Units: Subjects
        Female
    15 15
        Male
    11 11
    Subject analysis sets

    Subject analysis set title
    All patients
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All patients entering treatment period

    Subject analysis sets values
    All patients
    Number of subjects
    26
    Age Categorical
    Units: Subjects
    Age Continuous
    Gestational age at birth
    Units: weeks
        arithmetic mean (full range (min-max))
    32.1 (23 to 41)
    Gender Categorical
    Units: Subjects
        Female
    15
        Male
    11

    End points

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    End points reporting groups
    Reporting group title
    Esomeprazole treatment
    Reporting group description
    Esomeprazole 0.5 mg/kg

    Subject analysis set title
    All patients
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All patients entering treatment period

    Primary: AUCτ

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    End point title
    AUCτ [1]
    End point description
    Geometric mean of AUCτ (µmol*h/L) after 7 days of oral administration
    End point type
    Primary
    End point timeframe
    After 7 days of oral administration
    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 analysis skpecifed, because it is a single arm study. Only discriptive statistics are presented.
    End point values
    Esomeprazole treatment
    Number of subjects analysed
    24
    Units: µmol*h/L
        geometric mean (confidence interval 95%)
    2.45 (1.63 to 3.68)
    No statistical analyses for this end point

    Secondary: Css,max

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    End point title
    Css,max
    End point description
    Geometric mean Css,max (µmol/L) after 7 days oral administration
    End point type
    Secondary
    End point timeframe
    After 7 days oral administration
    End point values
    Esomeprazole treatment
    Number of subjects analysed
    24
    Units: µmol/L
        geometric mean (confidence interval 95%)
    0.74 (0.54 to 1)
    No statistical analyses for this end point

    Secondary: Change from baseline in percentage of time with intragastric pH>4

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    End point title
    Change from baseline in percentage of time with intragastric pH>4
    End point description
    Change from baseline in percentage of time (over 24 hours) with intragastric pH>4
    End point type
    Secondary
    End point timeframe
    from baseline to after 7 days oral administration
    End point values
    Esomeprazole treatment
    Number of subjects analysed
    17
    Units: Percent
        arithmetic mean (confidence interval 95%)
    39.6 (28.9 to 50.3)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During 1 week treatment period and follow-up
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9
    Reporting groups
    Reporting group title
    Esomeprazole
    Reporting group description
    esomeprazole 0.5 mg/kg

    Reporting group title
    Follow-up
    Reporting group description
    The period between time of administration of the investigational product Day 7 plus 24 hours, and the follow-up visit.

    Serious adverse events
    Esomeprazole Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Pertussis
    Additional description: During follow-up period hospitalised due to pertussis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Esomeprazole Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 26 (30.77%)
    4 / 25 (16.00%)
    Investigations
    Blood urine present
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    apnoea
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Choking
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Cyanosis neonatal
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Eye discharge
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    General disorders and administration site conditions
    Oedema
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Pertussis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Skin candida
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         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
    20 Jan 2004
    The mode of administration was changed from per oral by tube or syringe to per oral via a specially designed funnel pan
    01 Jul 2004
    An X-ray procedure was added at the pre-entry visit in order to confirm that the pH probe had been correctly positioned
    09 Sep 2004
    Due to slower recruitment than expected the recruitment period was prolonged

    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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