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    Clinical Trial Results:
    Changes in bile acid homeostasis and stool habits after cholecystectomy

    Summary
    EudraCT number
    2016-004692-53
    Trial protocol
    DK  
    Global end of trial date
    15 May 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Jun 2021
    First version publication date
    20 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SJ-434
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03168555
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Zealand University Hospital
    Sponsor organisation address
    Lykkebaekvej 1, DK-Koege, Denmark, 4600
    Public contact
    Department of Medicine, Zealand University Hospital Køge, 0045 47322400, chrbo@regionsjaelland.dk
    Scientific contact
    Department of Medicine, Zealand University Hospital Køge, 0045 47322400, chrbo@regionsjaelland.dk
    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 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Investigate changes in hormonal regulation (particularly by FGF19 and 7α-hydroxy-4-cholesten-3-one) and composition of the bile acid pool before and after elective cholecystectomy to deem the role of the intact gall bladder.
    Protection of trial subjects
    N/A
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 May 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
    Denmark: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    -

    Pre-assignment period milestones
    Number of subjects started
    23
    Intermediate milestone: Number of subjects
    Completed study visit 1 (pre-op): 22
    Number of subjects completed
    22

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Intercurrent disease, cholecystectomy cancelled: 1
    Period 1
    Period 1 title
    Pre-operative study visit
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    Meal with chenodeoxycholic acid
    Arm description
    Solid study meal with 1,250 mg chenodeoxycholic acid
    Arm type
    Experimental

    Investigational medicinal product name
    chenodeoxycholic acid
    Investigational medicinal product code
    ATC: A05AA01
    Other name
    CDCA, 3 alpha- 7 alpha dihydroxycholic acid, Chendiol, Xenbilox
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1,250 mg single dose (5 capsules of 25g mg)

    Number of subjects in period 1 [1]
    Meal with chenodeoxycholic acid
    Started
    22
    Completed
    18
    Not completed
    4
         Consent withdrawn by subject
    2
         Adverse event, non-fatal
    1
         Lost to follow-up
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 23 patients enrolled, one patient withdrew from the study before study visit one, and therefore did not start the baseline periode
    Period 2
    Period 2 title
    Post-operative study visit
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Meal with chenodeoxycholic acid
    Arm description
    Solid study meal with 1,250 mg chenodeoxycholic acid
    Arm type
    Experimental

    Investigational medicinal product name
    chenodeoxycholic acid
    Investigational medicinal product code
    ATC: A05AA01
    Other name
    CDCA, 3 alpha- 7 alpha dihydroxycholic acid, Chendiol, Xenbilox
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1,250 mg single dose (5 capsules of 25g mg)

    Number of subjects in period 2
    Meal with chenodeoxycholic acid
    Started
    18
    Completed
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pre-operative study visit
    Reporting group description
    -

    Reporting group values
    Pre-operative study visit Total
    Number of subjects
    22 22
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    54 (38 to 59) -
    Gender categorical
    Units: Subjects
        Female
    10 10
        Male
    12 12

    End points

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    End points reporting groups
    Reporting group title
    Meal with chenodeoxycholic acid
    Reporting group description
    Solid study meal with 1,250 mg chenodeoxycholic acid
    Reporting group title
    Meal with chenodeoxycholic acid
    Reporting group description
    Solid study meal with 1,250 mg chenodeoxycholic acid

    Primary: 150 minute increment in stimulated FGF19

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    End point title
    150 minute increment in stimulated FGF19
    End point description
    End point type
    Primary
    End point timeframe
    Comparison of visit 1 (pre-operative) with visit 2 (post-operative)
    End point values
    Meal with chenodeoxycholic acid Meal with chenodeoxycholic acid
    Number of subjects analysed
    18
    18
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    81 (-20 to 274)
    186 (111 to 382)
    Statistical analysis title
    Wilcoxon signed rank test
    Comparison groups
    Meal with chenodeoxycholic acid v Meal with chenodeoxycholic acid
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.03
    Method
    Wilcoxon (Mann-Whitney)
    Parameter type
    Median difference (net)
    Confidence interval

    Secondary: Change in fasting C4

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    End point title
    Change in fasting C4
    End point description
    End point type
    Secondary
    End point timeframe
    Comparing visit 2 with visit 1
    End point values
    Meal with chenodeoxycholic acid Meal with chenodeoxycholic acid
    Number of subjects analysed
    18
    18
    Units: ng/mL
        arithmetic mean (confidence interval 95%)
    6.0 (4.1 to 8.7)
    7.5 (5.5 to 10)
    Statistical analysis title
    paired t-test (of lognormalized base values)
    Statistical analysis description
    paired t-test (of lognormalized base values)
    Comparison groups
    Meal with chenodeoxycholic acid v Meal with chenodeoxycholic acid
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [1]
    P-value
    = 0.63
    Method
    Paired t-test
    Confidence interval
    Notes
    [1] - paired t-test (of lognormalized base values)

    Secondary: Change in total area under the curve of stimulated C4

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    End point title
    Change in total area under the curve of stimulated C4
    End point description
    End point type
    Secondary
    End point timeframe
    comparing visit 1 with visit 2
    End point values
    Meal with chenodeoxycholic acid Meal with chenodeoxycholic acid
    Number of subjects analysed
    18
    18
    Units: ng/mL x minutes
        arithmetic mean (confidence interval 95%)
    774 (524 to 1143)
    1040 (765 to 1417)
    Statistical analysis title
    paired t-test (of lognormalized base values)
    Comparison groups
    Meal with chenodeoxycholic acid v Meal with chenodeoxycholic acid
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.36
    Method
    Paired t-test
    Confidence interval

    Secondary: Change in fasting FGF19

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    End point title
    Change in fasting FGF19
    End point description
    End point type
    Secondary
    End point timeframe
    comparing viist 1 with visit 2
    End point values
    Meal with chenodeoxycholic acid Meal with chenodeoxycholic acid
    Number of subjects analysed
    18
    18
    Units: pg/mL
        arithmetic mean (confidence interval 95%)
    102 (74 to 141)
    92 (67 to 125)
    Statistical analysis title
    paired t-test (of lognormalized base values)
    Comparison groups
    Meal with chenodeoxycholic acid v Meal with chenodeoxycholic acid
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.29
    Method
    Paired t-test
    Confidence interval

    Secondary: Change in total area under the curve of stimulated chenodeoxycholic acid

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    End point title
    Change in total area under the curve of stimulated chenodeoxycholic acid
    End point description
    End point type
    Secondary
    End point timeframe
    comparing viist 1 with visit 2
    End point values
    Meal with chenodeoxycholic acid Meal with chenodeoxycholic acid
    Number of subjects analysed
    18
    18
    Units: µM x minutes
        median (inter-quartile range (Q1-Q3))
    1554 (1084 to 2231)
    1847 (1310 to 2193)
    Statistical analysis title
    Wilcoxon paired signed rank test
    Comparison groups
    Meal with chenodeoxycholic acid v Meal with chenodeoxycholic acid
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.22
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change in mean stools per day

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    End point title
    Change in mean stools per day
    End point description
    End point type
    Secondary
    End point timeframe
    comparing viist 1 with visit 2
    End point values
    Meal with chenodeoxycholic acid Meal with chenodeoxycholic acid
    Number of subjects analysed
    18
    18
    Units: Mean stool number
        median (inter-quartile range (Q1-Q3))
    1.6 (1.1 to 2.0)
    1.6 (1.3 to 1.7)
    Statistical analysis title
    Wilcoxon paired signed rank test
    Comparison groups
    Meal with chenodeoxycholic acid v Meal with chenodeoxycholic acid
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.73
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change in stool consistency

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    End point title
    Change in stool consistency
    End point description
    End point type
    Secondary
    End point timeframe
    comparing viist 1 with visit 2
    End point values
    Meal with chenodeoxycholic acid Meal with chenodeoxycholic acid
    Number of subjects analysed
    18
    18
    Units: Mean Bristol stool type
        median (inter-quartile range (Q1-Q3))
    4.2 (3.7 to 4.8)
    4.0 (3.6 to 4.5)
    Statistical analysis title
    Wilcoxon paired signed rank test
    Comparison groups
    Meal with chenodeoxycholic acid v Meal with chenodeoxycholic acid
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.8
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change in plasma triglycerides

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    End point title
    Change in plasma triglycerides
    End point description
    End point type
    Secondary
    End point timeframe
    comparing viist 1 with visit 2
    End point values
    Meal with chenodeoxycholic acid Meal with chenodeoxycholic acid
    Number of subjects analysed
    18
    18
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    1.4 (1.1 to 2.1)
    1.5 (1.1 to 1.9)
    Statistical analysis title
    Wilcoxon paired signed rank test
    Comparison groups
    Meal with chenodeoxycholic acid v Meal with chenodeoxycholic acid
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.32
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval

    Post-hoc: Change in total area under the curve of stimulated FGF19

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    End point title
    Change in total area under the curve of stimulated FGF19
    End point description
    End point type
    Post-hoc
    End point timeframe
    comparing viist 1 with visit 2
    End point values
    Meal with chenodeoxycholic acid Meal with chenodeoxycholic acid
    Number of subjects analysed
    18
    18
    Units: pg/mL x minutes
        arithmetic mean (confidence interval 95%)
    22323 (16658 to 29915)
    27582 (20478 to 37149)
    Statistical analysis title
    paired t-test (of lognormalized base values)
    Comparison groups
    Meal with chenodeoxycholic acid v Meal with chenodeoxycholic acid
    Number of subjects included in analysis
    36
    Analysis specification
    Post-hoc
    Analysis type
    equivalence
    P-value
    = 0.07
    Method
    Paired t-test
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collecter per study visit. One visit (visit 1) was before cholecystectomy and one visit (visit 2) was after cholecystectomy. At both visits a solid study meal with 1,250 mg chenodeoxycholic acid (IMP) was admisitered
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    SNOMED CT
    Dictionary version
    2021-03-31
    Reporting groups
    Reporting group title
    Visit 1 (pre-operative visit)
    Reporting group description
    -

    Reporting group title
    Visit2 (post-operative visit)
    Reporting group description
    -

    Serious adverse events
    Visit 1 (pre-operative visit) Visit2 (post-operative visit)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Visit 1 (pre-operative visit) Visit2 (post-operative visit)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 22 (100.00%)
    15 / 18 (83.33%)
    Nervous system disorders
    Headache
    Additional description: SNOMED 25064002
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Dizzyness
    Additional description: SNOMED 404640003
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Migraine
    Additional description: SNOMED 37796009
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Tiredness
    Additional description: SNOMED 224960004
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Abdominal bloating
    Additional description: SNOMED 116289008
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Nausea
    Additional description: SNOMED 422587007
         subjects affected / exposed
    3 / 22 (13.64%)
    1 / 18 (5.56%)
         occurrences all number
    3
    1
    Diarrhoea
    Additional description: SNOMED 62315008
         subjects affected / exposed
    14 / 22 (63.64%)
    14 / 18 (77.78%)
         occurrences all number
    14
    14
    Burping
    Additional description: SNOMED 271834000
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
    Additional description: SNOMED 21522001
         subjects affected / exposed
    3 / 22 (13.64%)
    5 / 18 (27.78%)
         occurrences all number
    3
    5
    Heartburn
    Additional description: SNOMED 16331000
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Malaise
    Additional description: SNOMED 367391008
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Abdominal sounds/growling
    Additional description: SNOMED 249503000
         subjects affected / exposed
    5 / 22 (22.73%)
    2 / 18 (11.11%)
         occurrences all number
    5
    2

    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
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