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    Clinical Trial Results:
    The effect of chlorpromazine (Largactil), a dopamine type 2-(D2-) receptor antagonist, on esophageal sensitivity in healthy volunteers: a randomized, double-blind, placebo-controlled study

    Summary
    EudraCT number
    		 2016-003131-38
    Trial protocol
    		 BE  
    Global end of trial date
    19 Oct 2017

    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)
    		 Thesis manuscript

    Trial information

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    Trial identification
    Sponsor protocol code
    DOPA2016
    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, TARGID, KU Leuven, 32 16344225, jan.tack@kuleuven.be
    Scientific contact
    TARGID, 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
    20 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of chlorpromazine (Largactil) on esophageal sensitivity in healthy subjects
    Protection of trial subjects
    Identification of trial subjects was protected by the implementation of subject numbers
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2017
    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: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    13
    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 for this study.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Chlorpromazine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Chlorpromazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ten mg chlorpromazine for IV infusion was added to 100mL NaCl 0.9%, infusion ran over 30 minutes.

    Arm title
    		 Placebo
    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
    100mL NaCl 0.9%, infusion ran over 30 minutes.

    Number of subjects in period 1
    		Chlorpromazine Placebo
    Started
    13
    13
    Completed
    13
    13

    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
    		 13 13
    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)
    		 13 13
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 25 (19 to 40) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 7 7

    End points

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Change in mechanical stimulation

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    End point title
    		 Change in mechanical stimulation
    End point description
    End point type
    Primary
    End point timeframe
    Between the two conditions
    End point values
    		 Chlorpromazine Placebo
    Number of subjects analysed
    13
    13
    Units: mL
        median (inter-quartile range (Q1-Q3))
    19.15 (17.9 to 25.65)
    24.33 (21.8 to 28.35)
    Statistical analysis title
    		 Paired t test for mechnical stimulation
    Comparison groups
    Chlorpromazine v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.53
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    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
    Reporting groups
    Reporting group title
    Chlorpromazine
    Reporting group description
    		 -

    Serious adverse events
    		 Chlorpromazine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Chlorpromazine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 13 (61.54%)
    Nervous system disorders
    Drowsiness
         subjects affected / exposed
    3 / 13 (23.08%)
         occurrences all number
    3
    Feeling of being tired
         subjects affected / exposed
    5 / 13 (38.46%)
         occurrences all number
    5

    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
    For support, Contact us.
    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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