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    Clinical Trial Results:
    Placebo-controlled crossover study of the ability of Naloxegol to reverse opioid effect on colonic motor patterns in healthy volunteers

    Summary
    EudraCT number
    		 2018-000013-20
    Trial protocol
    		 BE  
    Global end of trial date
    04 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Oct 2023
    First version publication date
    26 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2018-000013-20
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    KULeuven UZLeuven Targid
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Jan Tack, KU Leuven - Targid, 0032 16344225, jan.tack@kuleuven.be
    Scientific contact
    jan Tack, KU Leuven - Targid, 0032 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
    10 Jan 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to compare the effects of Naloxegol compared to placebo on colonic motility, in combination with the presence or absence of a mu-opioid agonist, codeine. This will be investigated in HVs using high-resolution colonic manometry. Our objective is to correlate colonic motor patterns or a decrease in overall colonic motility to the symptoms in opioid induced constipation.
    Protection of trial subjects
    healthy volunteers sedation catheter placement performed by experienced gastroenterologist
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 May 2018
    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: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 15 healthy volunteers

    Pre-assignment
    Screening details
    		 Normal bowel habit No organic or functional disease affecting the gastrointestinal system. No previous abdominal surgery other than appendectomy No intake of laxatives or other medications.

    Period 1
    Period 1 title
    overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 naloxegol
    Arm description
    		 Upon awakening, participants received naloxegol or matching placebo
    Arm type
    		 Active comparator

    Investigational medicinal product name
    naloxegol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants underwent a colonoscopy after a half dose of standard PEG preparation for colonic manometry catheter placement. Upon awakening, participants received naloxegol 25mg or matching placebo. In addition, placebo or 60 mg codeine was administered orally, followed by another intake of half this dose one-hour post-prandial.

    Arm title
    		 placebo
    Arm description
    		 Upon awakening, participants received naloxegol or matching placebo
    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
    Participants underwent a colonoscopy after a half dose of standard PEG preparation for colonic manometry catheter placement. Upon awakening, participants received naloxegol or matching placebo. In addition, placebo or 60 mg codeine was administered orally, followed by another intake of half this dose one-hour post-prandial

    Number of subjects in period 1
    		naloxegol placebo
    Started
    15
    15
    Completed
    15
    15

    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
    		 15 15
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 15 15
    Age continuous
    Units: years
        median (standard deviation)
    		 31.9 ( 3.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 6 6

    End points

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    End points reporting groups
    Reporting group title
    naloxegol
    Reporting group description
    		 Upon awakening, participants received naloxegol or matching placebo

    Reporting group title
    placebo
    Reporting group description
    		 Upon awakening, participants received naloxegol or matching placebo

    Primary: reversal effects of a peripheral-acting mu-opioid receptor antagonist (PAMORA) on colonic motor patterns

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    End point title
    		 reversal effects of a peripheral-acting mu-opioid receptor antagonist (PAMORA) on colonic motor patterns
    End point description
    End point type
    Primary
    End point timeframe
    3 study conditions naloxegol/placebo, placebo/codeine, or naloxegol/codeine
    End point values
    		 naloxegol placebo
    Number of subjects analysed
    14 [1]
    14 [2]
    Units: Colonic pressure waves
    14
    14
    Notes
    [1] - one participant was omitted from the analysis because of a missing trace
    [2] - one participant was omitted from the analysis because of a missing trace
    Statistical analysis title
    		 Colonic pressure waves
    Statistical analysis description
    Colonic pressure waves (PWs) were evaluated during sleep, in the fasted state, after a standardized bread meal (645 kcal), and after intraluminal administration of 10 mg bisacodyl. We analyzed the number and direction of propagation of short PWs (over 3-4 sensors), long PWs (>4 sensors), and high-amplitude propagating contractions (HAPCs; long PWs with an amplitude of ≥100 mmHg for at least 1 sensor and 2 sensors of ≥90 mmHg).
    Comparison groups
    naloxegol v placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.05
    Method
    		 Friedman test
    Confidence interval
    Notes
    [3] - Both short and long synchronous PWs did not occur statistically significantly more or less in one of the 3 conditions, for all time periods. The same result was found for the antegrade PWs in all time periods. Postprandially, long retrograde PWs occurred statistically significantly less often with naloxegol/placebo compared to placebo/codeine (p=0.04). Additionally, short retrograde PWs occurred less often with naloxegol/placebo than with placebo/codeine (p=0.03).

    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 in this study

    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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