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    Clinical Trial Results:
    Pharmacokinetics of Proton Pump Inhibitors in a random Icelandic Population.

    Summary
    EudraCT number
    		 2015-002230-41
    Trial protocol
    		 IS  
    Global end of trial date
    31 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Nov 2021
    First version publication date
    20 Nov 2021
    Other versions
    Summary report(s)
    		 Pharmacokinetics of single and repeated oral doses of esomeprazole and gastrin elevation in healthy males and females

    Trial information

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    Trial identification
    Sponsor protocol code
    PPH-LYF02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Landspitali – the National Univerity Hospital of Iceland.
    Sponsor organisation address
    Hringbraut , Reykjavik , Iceland, 101
    Public contact
    Einar Stefan Bjornsson, Landspitali University Hospital , landspitali@landspitali.is
    Scientific contact
    Einar Stefan Bjornsson, Landspitali University Hospital , 354 8253747, einarsb@landspitali.is
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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
    30 Nov 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this work is to identify the pharmacokinetics of proton pump inhibitors (PPI) after a single oral dose and after continuous intake for five days in healthy volunteers.
    Protection of trial subjects
    In this study no new medicines will be investigated, only authorized medicinal products on the European market. The study focuses on the question: is there a gender specific difference in the pharmacokinetic of PPIs? The PPI drugs have a very good safety profile and in this study 30 participants, ecually many males and females will only receive single dose each morning for five days, so safety should not be issue beyond the usual PPI therapy. In the Icelandic Health care system, in this case Landspitali, all patients are insured by Icelandic law. Landspitali as a part of the Icelandic socialized and governmental owned and organized health care system, carries its own central insurance plan, backed up by the ministries of Welfare and Finance. The volunteers participating in this study according to appropriately approved protocol, will be assured the same insurance coverage as all other patients receiving treatment at the hospital.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Sep 2015
    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
    Iceland: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    0
    Adults (18-64 years)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy volunteers were recruited by advertisements in the University Hospital of Iceland and the University of Iceland via email.

    Pre-assignment
    Screening details
    		 Only adults (aged 20 – 50 years) without a history of gastrointestinal (GI) symptoms or use of acid suppressive therapy were invited to participate. Individuals with known obesity (BMI>30kg/m2), chronic infectious diseases such as hepatitis, pregnant or taking known CYP inhibitors or inducers were excluded from the study

    Period 1
    Period 1 title
    Day 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Study arm
    Arm description
    		 This study was a non-blind 1-way trial consisting of 5-day study period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ezomeprazol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The participants received a single oral dose of 40 mg tablet of esomeprazole for five days

    Number of subjects in period 1
    		Study arm
    Started
    30
    Completed
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Day 1
    Reporting group description
    		 -

    Reporting group values
    		 Day 1 Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 30 30
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 15 15
    Subject analysis sets

    Subject analysis set title
    Day 5
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Healthy volunteers were recruited by advertisements in the University Hospital of Iceland and the University of Iceland via email. Only adults (aged 20–50 years) without a history of gastrointestinal (GI) symptoms or use of acid suppressive therapy were invited to participate.

    Subject analysis sets values
    		 Day 5
    Number of subjects
    30
    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)
    0
        Adults (18-64 years)
    30
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    15
        Male
    15

    End points

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    End points reporting groups
    Reporting group title
    Study arm
    Reporting group description
    		 This study was a non-blind 1-way trial consisting of 5-day study period.

    Subject analysis set title
    Day 5
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Healthy volunteers were recruited by advertisements in the University Hospital of Iceland and the University of Iceland via email. Only adults (aged 20–50 years) without a history of gastrointestinal (GI) symptoms or use of acid suppressive therapy were invited to participate.

    Primary: Pharmacokinetic parameters

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    End point title
    		 Pharmacokinetic parameters
    End point description
    End point type
    Primary
    End point timeframe
    The pharmacokinetic parameters (primary and secondary endpoints) were estimated using noncompartmental analysis on the serum esomeprazole concentration wit
    End point values
    		 Study arm Day 5
    Number of subjects analysed
    30
    30
    Units: ng/ml
        number (not applicable)
    30
    30
    Statistical analysis title
    		 Pharmacokinetic parameters
    Comparison groups
    Study arm v Day 5
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1000
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0
         upper limit
    		 -

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the drug intervention period
    Adverse event reporting additional description
    During the drug intervention period, researchers will be in telephone contact with participants to follow them up and participants are also given a telephone number to contact on their own initiative. Any unexpected serious adverse effects that may occur follow the drug intake will be notified to the Icelandic Medicines Agency.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no reports of non-serious adverse events recorded, most likely do to short proton pump inhibitor therapy of only 5 days

    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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    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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