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    Clinical Trial Results:
    Gastrointestinal behaviour of mesalazine in healthy volunteers

    Summary
    EudraCT number
    		 2019-001009-26
    Trial protocol
    		 BE  
    Global end of trial date
    25 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Feb 2023
    First version publication date
    07 Feb 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DDD19GISAM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Clinical Trial Center UZ Leuven: S62903
    Sponsors
    Sponsor organisation name
    KU Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Drug Delivery and Disposition, KU Leuven, +32 16329943, patrick.augustijns@kuleuven.be
    Scientific contact
    Drug Delivery and Disposition, KU Leuven, +32 16329943, patrick.augustijns@kuleuven.be
    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
    26 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The general aim is to assess the pharmacokinetic disposition of mesalazine in the upper gastrointestinal tract of healthy volunteers. To this end, the present study persues the sampling of gastric and intestinal fluids, and blood after oral delivery of a single dose of mesalazine, in addition of Nexiam (PPI) in fasted or fed state. Hereby, four conditions will be evaluated using a cross-over design to assess differences in release of mesalazine formulations.
    Protection of trial subjects
    Healthy volunteers xylocaine spray/gel during positioning and removal of nasogastric catheter
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Nov 2019
    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
    Belgium: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 heatlhy volunteers fulfilling inclusion/exclusion criteria were recruited

    Pre-assignment
    Screening details
    		 Exclusion criteria for participation included illness at the time of the study, allergy for salicylic derivatives, medication use (excluding contraceptives), history of acute/chronic GI disease(s), and pregnancy.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 pentasa (500 mg mesalazine)
    Arm description
    		 1. oral intake of one Pentasa tablet (500 mg mesalazine)
    Arm type
    		 control condition

    Investigational medicinal product name
    pentasa (500 mg mesalazine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    on the test day at the University Hospitals Leuven volunteers ingested one tablet of Pentasa with 240 mL of tap water

    Arm title
    		 claversal (500 mg mesalazine)
    Arm description
    		 2. oral intake of one Claversal tablet (500 mg mesalazine)
    Arm type
    		 control condition

    Investigational medicinal product name
    claversal (500 mg mesalazine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    on the test day at the University Hospitals Leuven volunteers ingested one tablet of Claversal with 240 mL of tap water (t = 0)

    Arm title
    		 PPI + pentasa (mesalazine 500 mg)
    Arm description
    		 3. oral intake of one Pentasa tablet (500 mg mesalazine) following PPI pre-treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    esomeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    For the PPI conditions, volunteers were pre-treated with a once-daily dose of Nexiam (40 mg esomeprazole, corresponding to the recommended daily dose) in the morning, starting two days prior to the test day; a third and final dose was taken in the morning of the test day.

    Investigational medicinal product name
    pentasa (500 mg mesalazine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    on the test day at the University Hospitals Leuven volunteers ingested one tablet of Pentasa with 240 mL of tap water

    Arm title
    		 PPI + claversal (500 mg mesalazine)
    Arm description
    		 4. oral intake of one Claversal tablet (500 mg mesalazine) following PPI pre-treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    claversal (500 mg mesalazine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    on the test day at the University Hospitals Leuven volunteers ingested one tablet of Claversal with 240 mL of tap water (t = 0)

    Investigational medicinal product name
    esomeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    For the PPI conditions, volunteers were pre-treated with a once-daily dose of Nexiam (40 mg esomeprazole, corresponding to the recommended daily dose) in the morning, starting two days prior to the test day; a third and final dose was taken in the morning of the test day.

    Number of subjects in period 1
    		pentasa (500 mg mesalazine) claversal (500 mg mesalazine) PPI + pentasa (mesalazine 500 mg) PPI + claversal (500 mg mesalazine)
    Started
    5
    5
    5
    5
    Completed
    5
    5
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall period
    Reporting group description
    		 -

    Reporting group values
    		 overall period Total
    Number of subjects
    		 5 5
    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)
    		 5 5
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 24 (22 to 26) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    pentasa (500 mg mesalazine)
    Reporting group description
    		 1. oral intake of one Pentasa tablet (500 mg mesalazine)

    Reporting group title
    claversal (500 mg mesalazine)
    Reporting group description
    		 2. oral intake of one Claversal tablet (500 mg mesalazine)

    Reporting group title
    PPI + pentasa (mesalazine 500 mg)
    Reporting group description
    		 3. oral intake of one Pentasa tablet (500 mg mesalazine) following PPI pre-treatment

    Reporting group title
    PPI + claversal (500 mg mesalazine)
    Reporting group description
    		 4. oral intake of one Claversal tablet (500 mg mesalazine) following PPI pre-treatment

    Primary: not applicable

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    End point title
    		 not applicable [1]
    End point description
    Since we only conduct observational tests in a few volunteers, statistical and hypothesis testing is not applicable.
    End point type
    Primary
    End point timeframe
    not applicable
    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: Since we only conduct observational tests in a few volunteers, statistical and hypothesis testing is not applicable.
    End point values
    		 pentasa (500 mg mesalazine) claversal (500 mg mesalazine) PPI + pentasa (mesalazine 500 mg) PPI + claversal (500 mg mesalazine)
    Number of subjects analysed
    5
    5
    5
    5
    Units: not applicable
    5
    5
    5
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    For each individual, corresponds to timeframe of study participation (from signing of informed consent until last visit).
    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 adverse events during the trial

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Sep 2020
    "The replacement of a double-lumen catheter by a jejunal catheter. This allows to aspirate further down the gastrointestinal tract (proximal jejunum). Restart study after Covid19 measures."

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35339635
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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
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