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    Clinical Trial Results:
    The effect of corticotropin release hormone on duodenal markers and gastric sensorimotor function in healthy volunteers

    Summary
    EudraCT number
    		 2021-000594-81
    Trial protocol
    		 BE  
    Global end of trial date
    22 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Nov 2025
    First version publication date
    20 Nov 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    S65020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZLeuven KULeuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    TARGID, KU Leuven UZLeuven, jan.tack@kuleuven.be
    Scientific contact
    TARGID, KU Leuven UZLeuven, 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
    12 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Part 1 ● The effect of corticotrophin release hormone (CRH) on duodenal mast cell count in healthy volunteers Part 2 ● The effect of CRH on sensitivity to gastric distention in healthy volunteers
    Protection of trial subjects
    Healthy volunteers
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 May 2021
    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: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 healthy volunteers public advertisement

    Pre-assignment
    Screening details
    		 Healthy volunteers (HVs) aged 18–55 yr old no history of abdominal surgeries no gastrointestinal symptoms. no individuals with systemic disease no medication, no pregnant or lactating women, no women contemplating pregnancy

    Period 1
    Period 1 title
    CRH and placebo on gastric function (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 CRH infusion
    Arm description
    		 HVs were randomized to receive either peripheral administered human CRH or placebo (0.9%NaCl), After an overnight fast, the HVs underwent a 4-h gastric emptying breath tests, body surface gastric mapping (BSGM) for gastric myoelectrical activity recording with symptomprofiling and, on separate days, a gastric barostat to assess gastric sensitivity and accommodation during CRH or placebo infusion
    Arm type
    		 Experimental

    Investigational medicinal product name
    CORTICOTROPIN-RELEASING HORMONE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intravenous bolus use , Intravenous use
    Dosage and administration details
    100 ug bolus and 1 ug/kg/h continuous infusion CRH (CRH Ferring, Ferring Pharmaceuticals, Germany)

    Arm title
    		 placebo infusion
    Arm description
    		 HVs were randomized to receive either peripheral administered human CRH or placebo (0.9%NaCl), After an overnight fast, the HVs underwent a 4-h gastric emptying breath tests, body surface gastric mapping (BSGM) for gastric myoelectrical activity recording with symptomprofiling and, on separate days, a gastric barostat to assess gastric sensitivity and accommodation during CRH or placebo infusion
    Arm type
    		 Placebo

    Investigational medicinal product name
    saline (0.9% NaCl, Baxter, Belgium)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use , Intravenous use
    Dosage and administration details
    1mL bolus and 0.1mL/kg/h continuous infusion

    Number of subjects in period 1
    		CRH infusion placebo infusion
    Started
    20
    20
    Completed
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CRH and placebo on gastric function
    Reporting group description
    		 -

    Reporting group values
    		 CRH and placebo on gastric function Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 20 20
    Age continuous
    20 healthy volunteers
    Units: years
        arithmetic mean (standard deviation)
    		 29.2 ( 5.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 7 7

    End points

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    End points reporting groups
    Reporting group title
    CRH infusion
    Reporting group description
    		 HVs were randomized to receive either peripheral administered human CRH or placebo (0.9%NaCl), After an overnight fast, the HVs underwent a 4-h gastric emptying breath tests, body surface gastric mapping (BSGM) for gastric myoelectrical activity recording with symptomprofiling and, on separate days, a gastric barostat to assess gastric sensitivity and accommodation during CRH or placebo infusion

    Reporting group title
    placebo infusion
    Reporting group description
    		 HVs were randomized to receive either peripheral administered human CRH or placebo (0.9%NaCl), After an overnight fast, the HVs underwent a 4-h gastric emptying breath tests, body surface gastric mapping (BSGM) for gastric myoelectrical activity recording with symptomprofiling and, on separate days, a gastric barostat to assess gastric sensitivity and accommodation during CRH or placebo infusion

    Primary: gastric emptying rate

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    End point title
    		 gastric emptying rate
    End point description
    Compared with placebo, infusion of CRH significantly decreased the T1/2, compared with placebo (65.2 ± 17.4 vs. 78.8 ± 24.5min, P = 0.02).
    End point type
    Primary
    End point timeframe
    active period (CRH) vs placebo period
    End point values
    		 CRH infusion placebo infusion
    Number of subjects analysed
    20
    20
    Units: minute
        arithmetic mean (standard deviation)
    65.2 ( 17.4 )
    78.8 ( 24.5 )
    Statistical analysis title
    		 gastric emptying rate
    Comparison groups
    CRH infusion v placebo infusion
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.02
    Method
    		 t-test, 1-sided
    Parameter type
    		 Mean difference (final values)
    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 until 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: 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: No adverse events were experienced / registered during this study

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/38375576
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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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