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    Clinical Trial Results:
    THE RELATIONSHIP BETWEEN GASTRIC MOTILITY AND EMPTYING AS MEASURED WITH AN INTRAGASTRIC BALLOON AND BREATH TESTING

    Summary
    EudraCT number
    		 2016-002889-32
    Trial protocol
    		 BE  
    Global end of trial date
    15 Mar 2017

    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
    CodeineII
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    KULeuven UZLeuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    TARGID, KU Leuven, 32 163474425, pieter.janssen@kuleuven.be
    Scientific contact
    TARGID, KU Leuven, 32 16344225, jan.tack@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
    24 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to investigate the relation between gastric motility and gastric emptying in healthy control volunteers (codeine vs. placebo).
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Aug 2016
    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: 6
    Worldwide total number of subjects
    6
    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)
    0
    Adults (18-64 years)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 healty volunteers were recruited

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 20 ml balloon + codeine
    Arm description
    		 20 ml balloon + 60 mg codeine
    Arm type
    		 Experimental

    Investigational medicinal product name
    codeine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    Codeine was administrated as a syrup: Bronchodine® 10mg 5ml-1. dose 60 mg codein = 30 ml bronchodine syrup was administered

    Arm title
    		 200 ml balloon + codeine
    Arm description
    		 200 ml balloon + 60 mg codeine
    Arm type
    		 Experimental

    Investigational medicinal product name
    codeine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    Codeine was administrated as a syrup: Bronchodine® 10mg 5ml-1. dose 60 mg codein = 30 ml bronchodine syrup was administered

    Arm title
    		 20 ml balloon + placebo
    Arm description
    		 20 ml balloon + placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    30 ml of a homeopathic syrup was administrated (Drosetux)

    Arm title
    		 200 ml balloon + placebo
    Arm description
    		 200 ml balloon + placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    30 ml of a homeopathic syrup was administrated (Drosetux)

    Number of subjects in period 1
    		20 ml balloon + codeine 200 ml balloon + codeine 20 ml balloon + placebo 200 ml balloon + placebo
    Started
    6
    6
    6
    6
    Completed
    6
    6
    6
    6

    Baseline characteristics

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

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 6 6
    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)
    		 6 6
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    20 ml balloon + codeine
    Reporting group description
    		 20 ml balloon + 60 mg codeine

    Reporting group title
    200 ml balloon + codeine
    Reporting group description
    		 200 ml balloon + 60 mg codeine

    Reporting group title
    20 ml balloon + placebo
    Reporting group description
    		 20 ml balloon + placebo

    Reporting group title
    200 ml balloon + placebo
    Reporting group description
    		 200 ml balloon + placebo

    Primary: gastric contractility (balloon 200ml, codein vs placebo)

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    End point title
    		 gastric contractility (balloon 200ml, codein vs placebo) [1]
    End point description
    Contractility is expressed as motility index (MI) MI = balloon pressure motility index. Within the inflated condition, treatment (placebo or codeine) had a significant effect on MI (P<0.01). Within the deflated condition, treatment did not significantly affect MI.
    End point type
    Primary
    End point timeframe
    comparison of 2 conditions (balloon 200 ml + codeine vs balloon 200 ml + placebo) at timepoint 35 minutes.
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: this is a cross over study with 2 condiditions (balloon 20 ml and balloon 200 ml) and 2 products (codein and plabebo)
    End point values
    		 200 ml balloon + codeine 200 ml balloon + placebo
    Number of subjects analysed
    6
    6
    Units: Motility Index (MI)
        arithmetic mean (standard deviation)
    2.4 ( 1.3 )
    4.3 ( 1.8 )
    Statistical analysis title
    		 gastric contractility at timepoint 35 min
    Comparison groups
    200 ml balloon + codeine v 200 ml balloon + placebo
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.01
    Method
    		 ANOVA
    Confidence interval

    Primary: gastric contractility (balloon 20 ml, codein vs placebo)

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    End point title
    		 gastric contractility (balloon 20 ml, codein vs placebo) [2]
    End point description
    Contractility is expressed as motility index (MI) MI = balloon pressure motility index. Within the inflated condition, treatment (placebo or codeine) had a significant effect on MI (P<0.01). Within the deflated condition, treatment did not significantly affect MI.
    End point type
    Primary
    End point timeframe
    comparison of 2 conditions (balloon 20 ml + codeine vs balloon 20 ml + placebo) at timepoint 35 minutes.
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: this is a cross over study with 2 condiditions (balloon 20 ml and balloon 200 ml) and 2 products (codein and plabebo)
    End point values
    		 20 ml balloon + codeine 20 ml balloon + placebo
    Number of subjects analysed
    6
    6
    Units: Motility Index (MI)
        arithmetic mean (standard deviation)
    1.7 ( 1.7 )
    1.4 ( 1.4 )
    Statistical analysis title
    		 gastric contractility (balloon 20 ml)
    Comparison groups
    20 ml balloon + placebo v 20 ml balloon + codeine
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    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: 0%
    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: Different epigastric symptoms were systematically recorded at various stages during the experiment: bloating, discomfort, nausea and pain. Mild bloating and hunger were often present. These symptoms were not regarded as adverse events.

    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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