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    Clinical Trial Results:
    The effect of naloxone and methylnaltrexone on oesophageal sensitivity in healthy volunteers: a randomized, double-blind placebo controlled study.

    Summary
    EudraCT number
    		 2012-003409-86
    Trial protocol
    		 BE  
    Global end of trial date
    18 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Feb 2021
    First version publication date
    04 Feb 2021
    Other versions
    Summary report(s)
    		 Thesis manuscript

    Trial information

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    Trial identification
    Sponsor protocol code
    Methnalox2012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03014843
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    KULeuven UZLeuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    KU Leuven, TARGID, 32 16344225, jan.tack@kuleuven.be
    Scientific contact
    KU Leuven, TARGID, 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
    20 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the acute effect of naloxon and methylnaltrexone administered IV/SC on oesophageal sensitivity in healthy volunteers
    Protection of trial subjects
    The identification of trial subjects was protected by using an identification code.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Oct 2014
    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: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Healthy 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
    		 Methylnaltrexone subcutaneous + placebo infusion
    Arm description
    		 Methylnaltrexone (12mg/0.6mL subcutaneous injection) + infusion of placebo (NaCl 0.9%)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methylnaltrexone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    12mg/0.6mL methylnaltrexone

    Investigational medicinal product name
    Saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.9% NaCL via infusion

    Arm title
    		 Placebo subcutaneous + naloxone infusion
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.9% NaCL subcutaneous

    Investigational medicinal product name
    Naloxone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.4mg IV bolus injection followed by 20µg/kg/h IV infusion

    Arm title
    		 Placebo subcutaneous + placebo infusion
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravascular use , Subcutaneous use
    Dosage and administration details
    0.9% NaCl injected subcutaneous and infused intravascular

    Number of subjects in period 1
    		Methylnaltrexone subcutaneous + placebo infusion Placebo subcutaneous + naloxone infusion Placebo subcutaneous + placebo infusion
    Started
    12
    12
    12
    Completed
    12
    12
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 12 12
    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)
    		 12 12
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 31 (22 to 51) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 7 7

    End points

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    End points reporting groups
    Reporting group title
    Methylnaltrexone subcutaneous + placebo infusion
    Reporting group description
    		 Methylnaltrexone (12mg/0.6mL subcutaneous injection) + infusion of placebo (NaCl 0.9%)

    Reporting group title
    Placebo subcutaneous + naloxone infusion
    Reporting group description
    		 -

    Reporting group title
    Placebo subcutaneous + placebo infusion
    Reporting group description
    		 -

    Primary: Change in mechanical stimulation between methylnaloxone, naloxone and placebo

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    End point title
    		 Change in mechanical stimulation between methylnaloxone, naloxone and placebo
    End point description
    End point type
    Primary
    End point timeframe
    Comparison between 3 conditions
    End point values
    		 Methylnaltrexone subcutaneous + placebo infusion Placebo subcutaneous + naloxone infusion Placebo subcutaneous + placebo infusion
    Number of subjects analysed
    12
    12
    12
    Units: mL at pain perception threhold
        median (inter-quartile range (Q1-Q3))
    19.4 (17.51 to 25.79)
    22.78 (15.61 to 40.03)
    23.4 (20.81 to 41.94)
    Statistical analysis title
    		 Mechanical stimulation ANOVA
    Comparison groups
    Placebo subcutaneous + placebo infusion v Methylnaltrexone subcutaneous + placebo infusion v Placebo subcutaneous + naloxone infusion
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.33
    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 untill 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: Headache and hunger was recorded during the experiment in some subjects. These non-serious adverse events are to be expected since the subjects needed to be fasted for this study. These symptoms were not regareded 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.
    Small number of subjects included in this study. Technical problems leading to unreliable data for some measurable variables for some subjects.
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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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