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    Clinical Trial Results:
    The effect of mirtazapine (REMERGON®) on gastric motility and satiation in healthy subjects

    Summary
    EudraCT number
    		 2014-004862-89
    Trial protocol
    		 BE  
    Global end of trial date
    23 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Feb 2021
    First version publication date
    14 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    mirtazapine1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZLeuven / KULeuven / TARGID
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Jan Tack, UZLeuven / KULeuven / TARGID, 0032 16344225, jan.tack@kuleuven.be
    Scientific contact
    Florencia Carbone, UZLeuven / KULeuven / TARGID, 0032 16377535, florencia.carbone@med.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
    22 Nov 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the study is to investigate the mechanism of work of mitrazipine (Remergon) in gastric motility and sensivity, and satiation in healthy volunteers.
    Protection of trial subjects
    not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Feb 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
    Belgium: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    31
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy volunteers had to be devoid of GI symptoms and of the use of medications known to influence gastrointestinal sensorimotor function.

    Pre-assignment
    Screening details
    		 Healthy volunteers, recruited by public advertisement

    Period 1
    Period 1 title
    overal study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 mirtazapine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    mirtazapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment consisted of a 3-week dosing of mirtazapine (15 mg) every night before sleeping for 3 weeks

    Arm title
    		 placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment consisted of a 3-week dosing of 1 placebo tablet every night before sleeping for 3 weeks

    Number of subjects in period 1
    		mirtazapine placebo
    Started
    16
    15
    Completed
    14
    14
    Not completed
    2
    1
         Adverse event, non-fatal
    1
    -
         intolerance of barostat procedure
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    mirtazapine
    Reporting group description
    		 -

    Reporting group title
    placebo
    Reporting group description
    		 -

    Reporting group values
    		 mirtazapine placebo Total
    Number of subjects
    		 16 15 31
    Age categorical
    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)
    		 0 0 0
        Adults (18-64 years)
    		 16 15 31
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 23.9 ( 1.3 ) 24.9 ( 1.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9 18
        Male
    		 7 6 13

    End points

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    End points reporting groups
    Reporting group title
    mirtazapine
    Reporting group description
    		 -

    Reporting group title
    placebo
    Reporting group description
    		 -

    Primary: The effect of mirtazapine on intragastric volume after a meal

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    End point title
    		 The effect of mirtazapine on intragastric volume after a meal
    End point description
    End point type
    Primary
    End point timeframe
    the effect of mirtazapine/placebo on gastric accommodation was measured with gastric barostat measurement at the end of a 3 week treatment with mirtazapine / placebo
    End point values
    		 mirtazapine placebo
    Number of subjects analysed
    14
    14
    Units: ml
        arithmetic mean (standard deviation)
    216.23 ( 29.25 )
    297.17 ( 40.65 )
    Statistical analysis title
    		 gastric accommodation after 3 week treatment
    Statistical analysis description
    At baseline, the meal-induced increase in intragastric balloon volume (accommodation) was similar in both treatment groups (placebo: 271.49±42.67 mL and mirtazapine: 206.08±50.5 mL, P=.24). No differences were observed after 3 weeks of treatment with placebo (297.17±40.65 mL; P=.69). After 3 weeks of treatment with mirtazapine, the intragastric barostat balloon volume was not significantly altered (216.23±29.25 mL; P=.85).
    Comparison groups
    mirtazapine v placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05 [1]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - In all analyses, P <.05 was considered statistically significant. No significant differences were found in the gastric accommodation.

    Adverse events

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    Adverse events information
    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
    Reporting groups
    Reporting group title
    mirtazapine arm
    Reporting group description
    		 -

    Reporting group title
    placebo group
    Reporting group description
    		 -

    Serious adverse events
    		 mirtazapine arm placebo group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (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
    		 mirtazapine arm placebo group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 16 (62.50%)
    6 / 15 (40.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 16 (25.00%)
    3 / 15 (20.00%)
         occurrences all number
    4
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 16 (50.00%)
    2 / 15 (13.33%)
         occurrences all number
    8
    2
    Dizziness
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Gastroenteritis
         subjects affected / exposed
    2 / 16 (12.50%)
    2 / 15 (13.33%)
         occurrences all number
    2
    2
    Skin and subcutaneous tissue disorders
    Skin reaction
    Additional description: urticarial rash
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28695632
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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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