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    Clinical Trial Results:
    Effect of citalopram on fasting and postprandial lower esophageal sphincter function in healthy subjects: a double-blind, placebo-controlled, randomized, cross-over study

    Summary
    EudraCT number
    		 2016-000563-16
    Trial protocol
    		 BE  
    Global end of trial date
    07 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Feb 2021
    First version publication date
    06 Feb 2021
    Other versions
    Summary report(s)
    		 Article citalopram on LES

    Trial information

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    Trial identification
    Sponsor protocol code
    Citalopram2016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03746691
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    TARGID
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    TARGID, TARGID, 32 16344225, jan.tack@kuleuven.be
    Scientific contact
    TARGID, 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
    04 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of citalopram on fasting and postprandial lower esophageal sphincter function in healthy subjects
    Protection of trial subjects
    Subject identification was replaced by identification number.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Mar 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: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy volunteers were recruited for this study.

    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
    		 Citalopram
    Arm description
    		 20 mg of citalopram (0.5 mL) (Cipramil, Lundbeck) or placebo (0.5 ml saline) was administered intraveneously over 30 min, using 100 mL saline 0.9% NaCl as vector
    Arm type
    		 Experimental

    Investigational medicinal product name
    Citalopram
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg of citalopram (0.5 mL) (Cipramil, Lundbeck) or placebo (0.5 ml saline) was administered iv over 30 min, using 100 mL saline 0.9% NaCl as vector

    Arm title
    		 Placebo
    Arm description
    		 Following a 10‐min stabilization placebo (0.5 ml saline) was administered intraveneous over 30 min, using 100 mL saline 0.9% NaCl as vector
    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
    Following a 10‐min stabilization period after the placement of the catheter, placebo (0.5 ml saline) was administered iv over 30 min, using 100 mL saline 0.9% NaCl as vector

    Number of subjects in period 1
    		Citalopram Placebo
    Started
    16
    16
    Completed
    16
    16

    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
    		 16 16
    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)
    		 16 16
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 23.9 ( 0.39 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Citalopram
    Reporting group description
    		 20 mg of citalopram (0.5 mL) (Cipramil, Lundbeck) or placebo (0.5 ml saline) was administered intraveneously over 30 min, using 100 mL saline 0.9% NaCl as vector

    Reporting group title
    Placebo
    Reporting group description
    		 Following a 10‐min stabilization placebo (0.5 ml saline) was administered intraveneous over 30 min, using 100 mL saline 0.9% NaCl as vector

    Primary: Change in LES pressure

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    End point title
    		 Change in LES pressure
    End point description
    End point type
    Primary
    End point timeframe
    Comparison of two conditions
    End point values
    		 Citalopram Placebo
    Number of subjects analysed
    16
    16
    Units: mmHg
        arithmetic mean (standard error)
    14.1 ( 1.6 )
    11.8 ( 1.2 )
    Statistical analysis title
    		 Paired t test for LES pressure
    Comparison groups
    Placebo v Citalopram
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.01
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From signing informed content 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: Headache, hunger and nausea was reported during this study. However these symptoms are due to the fact that the subjects needed to be fasted for this study and not due to the administration of citalopram, since these symptoms are both present in the placebo and the citalopram arm.

    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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