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    Clinical Trial Results:
    Effect of methylnaltrexone on intragastric pressure, the occurrence of transient lower esophageal sphincter relaxations and reflux events in healthy subjects: a double-blind, placebo-controlled, randomized, cross-over study

    Summary
    EudraCT number
    2016-000532-17
    Trial protocol
    BE  
    Global end of trial date
    12 Oct 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Feb 2021
    First version publication date
    07 Feb 2021
    Other versions
    Summary report(s)
    Article methylnaltrexone on TLESRs

    Trial information

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    Trial identification
    Sponsor protocol code
    Methylnaltrexone2016
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    TARGID
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    TARGID, K.U. Leuven, 32 16344225, jan.tack@kuleuven.be
    Scientific contact
    TARGID, K.U. 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
    03 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of methylnaltrexone on intragastric pressure, the occurrence of transient lower esophageal sphincter relaxations and reflux events in healthy subjects
    Protection of trial subjects
    Identification of trial subjects was protected by implementation of subject numbers.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Jun 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: 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
    -

    Pre-assignment
    Screening details
    Healthy volunteers were included in this study

    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
    -
    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
    subcutaneous injection of 12 mg methylnaltrexone (Relistor®; Wyeth Pharmaceucals, Louvain- la- Neuve, Belgium; 0.6 mL)

    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
    intravenous infusion of saline (bolus injecton of 1 mL followed by a continuous infusion of 100 mL/h),

    Arm title
    Methylnaltrexone subcutaneous + naloxone infusion
    Arm description
    -
    Arm type
    Active comparator

    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
    subcutaneous injection of 12 mg methylnaltrexone (Relistor®; Wyeth Pharmaceucals, Louvain- la- Neuve, Belgium; 0.6 mL)

    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
    intravenous infusion of naloxone (0.4 mg intravenous bolus [1 mL] followed by continuous infusion 20 μg/kg/h [100 mL/h]; ‘Narcan’, Bristol- Myers Squibb Pharma, Braine- l’Alleud, Belgium

    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 infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    intravenous infusion of saline (bolus injecton of 1 mL followed by a continuous infusion of 100 mL/h),

    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
    subcutaneous injection of saline

    Number of subjects in period 1
    Methylnaltrexone subcutaneous + placebo infusion Methylnaltrexone subcutaneous + naloxone infusion Placebo subcutaneous + placebo infusion
    Started
    15
    15
    15
    Completed
    15
    15
    15

    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
    15 15
    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)
    15 15
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    34.1 (18 to 42) -
    Gender categorical
    Units: Subjects
        Female
    9 9
        Male
    6 6

    End points

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    End points reporting groups
    Reporting group title
    Methylnaltrexone subcutaneous + placebo infusion
    Reporting group description
    -

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

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

    Primary: Number of TLESRs

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    End point title
    Number of TLESRs
    End point description
    End point type
    Primary
    End point timeframe
    Comparison between three conditions
    End point values
    Methylnaltrexone subcutaneous + placebo infusion Methylnaltrexone subcutaneous + naloxone infusion Placebo subcutaneous + placebo infusion
    Number of subjects analysed
    15
    15
    15
    Units: Number of TLESRs
        arithmetic mean (standard deviation)
    7.2 ( 1.3 )
    7.3 ( 1.6 )
    8.6 ( 1.3 )
    Statistical analysis title
    ANOVA number of TLESRs
    Comparison groups
    Methylnaltrexone subcutaneous + naloxone infusion v Methylnaltrexone subcutaneous + placebo infusion v Placebo subcutaneous + placebo infusion
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    < 0.05
    Method
    ANOVA
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From signing the informed consent until the end of the last study 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: Hunger was reported in the three different conditions. Hunger was caused by the study protocol (subjects needed to be fasted durng the study visits) and not due to the study medication

    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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