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    Clinical Trial Results:
    The effect of corticotrophin-releasing hormone (CRH) on esophageal motility in healthy volunteers

    Summary
    EudraCT number
    		 2014-002239-33
    Trial protocol
    		 BE  
    Global end of trial date
    01 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)
    		 Article CRH on esophageal motility

    Trial information

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    Trial identification
    Sponsor protocol code
    CRHMOT2014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02674256
    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 1633 06 71, jan.tack@kuleuven.be
    Scientific contact
    TARGID, TARGID, KU Leuven, 32 1633 06 71, 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
    01 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determine the effect of CRH-administration on esophageal motility in a group of healthy volunteers
    Protection of trial subjects
    The identification of all trial subjects was protected by using subject numbers.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 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: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    14
    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 not allowed to have any gastro-intestinal complaints. The use of medication, except for oral contraceptives, was not allowed for this study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Post CRH
    Arm description
    		 solution of 100µg CRH powder for injection in 1 mL of NaCL 0.9% was injected intravenous over the course of 1 minute
    Arm type
    		 Experimental

    Investigational medicinal product name
    cortisol releasing hormone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    100µg CRH powder in 1 mL of NaCL 0.9% was injected intravenous over the course of 1 minute

    Arm title
    		 Pre CRH
    Arm description
    		 Baseline values
    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
    NaCl 0.9%

    Number of subjects in period 1
    		Post CRH Pre CRH
    Started
    14
    14
    Completed
    14
    14

    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
    		 14 14
    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)
    		 14 14
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 26.6 ± 5.8 -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Post CRH
    Reporting group description
    		 solution of 100µg CRH powder for injection in 1 mL of NaCL 0.9% was injected intravenous over the course of 1 minute

    Reporting group title
    Pre CRH
    Reporting group description
    		 Baseline values

    Primary: Distal contractile integral

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    End point title
    		 Distal contractile integral
    End point description
    End point type
    Primary
    End point timeframe
    This endpoint was measured at the same visit. The value of the distal contractile integral pre and post injection of CRH
    End point values
    		 Post CRH Pre CRH
    Number of subjects analysed
    14
    14
    Units: mmHg.s.cm
        median (inter-quartile range (Q1-Q3))
    686 (541.3 to 1149)
    1391 (926 to 2035)
    Statistical analysis title
    		 T test for DCI
    Comparison groups
    Post CRH v Pre CRH
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0012
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were reported from the moment the subjects signed the informed consent until the end of their last study visit.
    Assessment type
    		 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 and hunger was reported during this study. This was due to the fact that the volunteers needed to be fasted for the investigation. These adverse events were not related to the adminstration of cortisol releasing hormone.

    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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