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    Clinical Trial Results:
    Peripheral Histamine 1 receptor blockage in Irritable Bowel Syndrome: multicentric trial

    Summary
    EudraCT number
    		 2013-001199-39
    Trial protocol
    		 BE  
    Global end of trial date
    02 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2025
    First version publication date
    27 Apr 2025
    Other versions
    Summary report(s)
    		 Article ebastine vs. placebo

    Trial information

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    Trial identification
    Sponsor protocol code
    MulticenterEbastineIBS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01908465
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 EC UZ Leuven S-number: S55485
    Sponsors
    Sponsor organisation name
    UZ Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium,
    Public contact
    TARGID, KU Leuven, guy.boeckxstaens@kuleuven.be
    Scientific contact
    TARGID, KU Leuven, guy.boeckxstaens@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
    07 Dec 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Relief of global symptoms of Irritable Bowel Syndrome (IBS), as well as abdominal pain in IBS
    Protection of trial subjects
    In case of troublesome side effects of an allergic reaction to the medicine used, the treatment was stopped immediately. Every adverse event was reported in the eCRF.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 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
    Netherlands: 22
    Country: Number of subjects enrolled
    Belgium: 181
    Worldwide total number of subjects
    203
    EEA total number of subjects
    203
    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)
    203
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from the outpatient clinic of the participating centers.

    Pre-assignment
    Screening details
    		 Inclusion criteria: - Rome III criteria - No organic cause of symptoms - Age 18-65 Exclusion criteria: - IBS constipation predominant - history of coeliakie, lactose-intolerance, ... - medication: anti-histaminics, antidepressants, antipsychotics - symptoms started after operation in abdominal cavity

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ebastine
    Arm description
    		 20 mg ebastine, once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    ebastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet/day (around the same time every day), 20mg

    Arm title
    		 Placebo
    Arm description
    		 Placebo, once daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet per day, around the same time every day

    Number of subjects in period 1 [1]
    		Ebastine Placebo
    Started
    101
    101
    Completed
    90
    87
    Not completed
    11
    14
         Consent withdrawn by subject
    3
    3
         Adverse event, non-fatal
    2
    2
         Lost to follow-up
    6
    8
         Lack of efficacy
    -
    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: One patient was excluded from the baseline period full analysis set because of a diagnosis of bile acid diarrhea (= exclusion) after enrollment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ebastine
    Reporting group description
    		 20 mg ebastine, once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, once daily

    Reporting group values
    		 Ebastine Placebo Total
    Number of subjects
    		 101 101 202
    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
        arithmetic mean (standard deviation)
    		 32 ( 12 ) 32 ( 11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 68 70 138
        Male
    		 33 31 64

    End points

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    End points reporting groups
    Reporting group title
    Ebastine
    Reporting group description
    		 20 mg ebastine, once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, once daily

    Subject analysis set title
    IBS-D/ebastine
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with IBS subtype diarrhea were evaluated for the effect of ebastine on stool consistency

    Subject analysis set title
    IBS-D/placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with IBS subtype diarrhea were evaluated for the effect of ebastine on stool consistency

    Primary: Responder rates for clinical response

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    End point title
    		 Responder rates for clinical response
    End point description
    1. Abdominal pain intensity (API): API was assessed daily using a 10-point Visual Analogue Scale. For each week, an average pain score of the worst abdominal pain per day was calcualated. Then, the change in weekly pain score was calculated from the average pain score recorded during the screening phase (baseline). An API weekly responder is defined as a subject who had a decrease of≥30% compared with baseline. 2. Global Relief of Symptoms (GRS): GRS was assessed weekly using a 6-point scale for 12 weeks during treatment and runout. A subject is considered as a GRS weekly responder if he/ she scores total or considerable relief of symptoms compared with baseline. A study subject is considered as a weekly clinical responder for a particular week if the subject was both an API and GRS responder. Using this definition, a study subject will be defined as a ‘clinical responder’ if he/she is a weekly Clinical Responder for at least 6 of the 12 weeks of treatment.
    End point type
    Primary
    End point timeframe
    API was assessed daily, for 12 weeks of treatment and run-out period. GRS was assessed weekly, for 12 weeks of treatment and run-out period.
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    90
    86
    Units: Subjects
    22
    13
    Statistical analysis title
    		 RD - Clinical response rate FAS
    Statistical analysis description
    Response rates and p values were determined using multiple imputation with 100 imputations to account for missing data. FAS = full analysis set
    Comparison groups
    Ebastine v Placebo
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0471
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 15.2

    Primary: Responder rate for GRS

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    End point title
    		 Responder rate for GRS
    End point description
    A subject was defined as a GRS responder if he/she reported total or obvious relief of symptoms compared with baseline for at least 6 of the 12 weeks of treatment.
    End point type
    Primary
    End point timeframe
    GRS was assessed weekly, for 12 weeks of treatment and run-out period.
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    88
    85
    Units: Subjects
    22
    17
    Statistical analysis title
    		 RD -Global relief of symptoms response rate FAS
    Statistical analysis description
    Response rates and p values were determined using multiple imputation with 100 imputations to account for missing data. FAS = full analysis set
    Comparison groups
    Ebastine v Placebo
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0715
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    8.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 17.1

    Primary: Responder rate for API

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    End point title
    		 Responder rate for API
    End point description
    An API-responder was defined as a patient who experienced an improvement in weekly average API of ≥30% compared with baseline for at least 6 of the 12 treatment weeks.
    End point type
    Primary
    End point timeframe
    API was assessed daily, for 12 weeks of treatment and run-out period.
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    92
    86
    Units: Subjects
    48
    32
    Statistical analysis title
    		 RD Abdominal pain intensity response rate FAS
    Comparison groups
    Ebastine v Placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0813
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    22.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 24.9

    Secondary: IBS-D clinical responders

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    End point title
    		 IBS-D clinical responders
    End point description
    In line with the primary endpoint, IBS-D clinical responders are defined as subjects that were weekly responders for both stool consistency and API during at least 6 of the 12 treatment weeks. A subject is considered a weekly responder for stool consistency if he/she experiences a ≥50% reduction in the number of days per week with at least one stool of type 6 or 7 on the BSFS compared with baseline.
    End point type
    Secondary
    End point timeframe
    Stool consistency was assessed daily for 12 weeks of treatment and run-out period.
    End point values
    		 IBS-D/ebastine IBS-D/placebo
    Number of subjects analysed
    61
    60
    Units: Subjects
    10
    4
    Statistical analysis title
    		 Stool consistency and API response (IBS-D)
    Comparison groups
    IBS-D/placebo v IBS-D/ebastine
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.1309
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    8.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 19

    Secondary: IBS-D Stool consistency responder

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    End point title
    		 IBS-D Stool consistency responder
    End point description
    A subject is considered a weekly responder for stool consistency if he/she experiences a ≥50% reduction in the number of days per week with at least one stool of type 6 or 7 on the BSFS compared with baseline. A subject was a stool consistency responder if the subject was a weekly responder during at least 6 of the 12 treatment weeks.
    End point type
    Secondary
    End point timeframe
    Stool consistency was assessed daily for 12 weeks of treatment and run-out.
    End point values
    		 IBS-D/ebastine IBS-D/placebo
    Number of subjects analysed
    59
    60
    Units: Subjects
    18
    17
    Statistical analysis title
    		 Stool consistency response (IBS-D) last 4 weeks
    Comparison groups
    IBS-D/ebastine v IBS-D/placebo
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.8046
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.3
         upper limit
    		 17.1

    Secondary: HADS anxiety score

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    End point title
    		 HADS anxiety score
    End point description
    Mental health and health-related quality of life questionnaire scores were compared between treatment groups and adjusted for baseline values
    End point type
    Secondary
    End point timeframe
    Filled out before and after treatment period (on visit 1 and visit 4)
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    88
    85
    Units: relative unit(s)
        median (inter-quartile range (Q1-Q3))
    0.00 (-2.00 to 2.00)
    0.00 (-3.00 to 1.00)
    Statistical analysis title
    		 Interaction clinical responder and HADS anxiety
    Statistical analysis description
    responder rates for 6 or more of the 12 treatment weeks for clinical response
    Comparison groups
    Ebastine v Placebo
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.7114
    Method
    		 Regression, Logistic
    Confidence interval

    Secondary: HADS depression score

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    End point title
    		 HADS depression score
    End point description
    Mental health and health-related quality of life questionnaire scores were compared between treatment groups and adjusted for baseline values
    End point type
    Secondary
    End point timeframe
    Filled out before and after treatment period (on visit 1 and visit 4)
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    88
    86
    Units: relative unit(s)
        median (inter-quartile range (Q1-Q3))
    0.00 (-2.00 to 1.00)
    -1.00 (-2.00 to 0.00)
    Statistical analysis title
    		 Interaction clinical responder - HADS depression
    Statistical analysis description
    responder rates for 6 or more of the 12 treatment weeks for clinical response
    Comparison groups
    Placebo v Ebastine
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.9146
    Method
    		 Regression, Logistic
    Confidence interval

    Secondary: SF-36 General Health

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    End point title
    		 SF-36 General Health
    End point description
    End point type
    Secondary
    End point timeframe
    Median change between baseline and week 12
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    101
    101
    Units: relative unit(s)
        median (inter-quartile range (Q1-Q3))
    40 (30 to 63)
    45 (30 to 60)
    No statistical analyses for this end point

    Secondary: SF-36 Bodily pain

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    End point title
    		 SF-36 Bodily pain
    End point description
    End point type
    Secondary
    End point timeframe
    Median change between baseline and week 12
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    101
    101
    Units: relative unit(s)
        median (inter-quartile range (Q1-Q3))
    45 (24 to 63)
    48 (35 to 58)
    No statistical analyses for this end point

    Secondary: SF-36 Social functioning

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    End point title
    		 SF-36 Social functioning
    End point description
    End point type
    Secondary
    End point timeframe
    Median change between baseline and week 12
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    101
    101
    Units: relative unit(s)
        median (inter-quartile range (Q1-Q3))
    63 (38 to 75)
    63 (50 to 75)
    No statistical analyses for this end point

    Secondary: SF-36 Mental health

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    End point title
    		 SF-36 Mental health
    End point description
    End point type
    Secondary
    End point timeframe
    Median change between baseline and week 12
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    101
    101
    Units: relative unit(s)
        median (inter-quartile range (Q1-Q3))
    66 (44 to 76)
    64 (52 to 76)
    No statistical analyses for this end point

    Secondary: SF-36 Vitality

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    End point title
    		 SF-36 Vitality
    End point description
    End point type
    Secondary
    End point timeframe
    Median change between baseline and week 12
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    101
    101
    Units: relative unit(s)
        median (inter-quartile range (Q1-Q3))
    43 (30 to 60)
    45 (30 to 55)
    No statistical analyses for this end point

    Secondary: SF-36 Role-emotional

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    End point title
    		 SF-36 Role-emotional
    End point description
    End point type
    Secondary
    End point timeframe
    Median change between baseline and week 12
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    101
    101
    Units: relative unit(s)
        median (inter-quartile range (Q1-Q3))
    100 (33 to 100)
    100 (33 to 100)
    No statistical analyses for this end point

    Secondary: SF-36 Role-physical

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    End point title
    		 SF-36 Role-physical
    End point description
    End point type
    Secondary
    End point timeframe
    Median change between baseline and week 12
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    101
    101
    Units: relative unit(s)
        median (inter-quartile range (Q1-Q3))
    25 (0 to 100)
    50 (0 to 75)
    No statistical analyses for this end point

    Secondary: SF-36 Physical functioning

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    End point title
    		 SF-36 Physical functioning
    End point description
    End point type
    Secondary
    End point timeframe
    Median change between baseline and week 12
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    101
    101
    Units: relative unit(s)
        median (inter-quartile range (Q1-Q3))
    89 (78 to 95)
    90 (75 to 95)
    No statistical analyses for this end point

    Post-hoc: Responder rate for clinical response (3/6)

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    End point title
    		 Responder rate for clinical response (3/6)
    End point description
    3/6 refers to at least 3 out of the last 6 weeks of the treatment period
    End point type
    Post-hoc
    End point timeframe
    API was assessed daily, for 12 weeks of treatment and run-out period. GRS was assessed weekly, for 12 weeks of treatment and run-out period.
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    89
    87
    Units: Subjects
    18
    8
    Statistical analysis title
    		 RD - clinical responder (3/6)
    Comparison groups
    Ebastine v Placebo
    Number of subjects included in analysis
    176
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 = 0.0386
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    10.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 19.8

    Post-hoc: Responder rate GRS (3/6)

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    End point title
    		 Responder rate GRS (3/6)
    End point description
    3/6 refers to at least 3 out of the last 6 weeks of the treatment period
    End point type
    Post-hoc
    End point timeframe
    GRS was assessed weekly, for 12 weeks of treatment and run-out period
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    87
    87
    Units: Subjects
    18
    11
    Statistical analysis title
    		 GRS clinical responder (3/6)
    Comparison groups
    Placebo v Ebastine
    Number of subjects included in analysis
    174
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 = 0.1748
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    7.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 18.2

    Post-hoc: Responder rate API (3/6)

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    End point title
    		 Responder rate API (3/6)
    End point description
    3/6 refers to at least 3 out of the last 6 weeks of the treatment period
    End point type
    Post-hoc
    End point timeframe
    API was assessed daily, for 12 weeks of treatment and run-out period.
    End point values
    		 Ebastine Placebo
    Number of subjects analysed
    92
    85
    Units: Subjects
    46
    28
    Statistical analysis title
    		 RD - API responder (3/6)
    Comparison groups
    Ebastine v Placebo
    Number of subjects included in analysis
    177
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 = 0.0378
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 29

    Post-hoc: Responder rate stool consistency (3/6)

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    End point title
    		 Responder rate stool consistency (3/6)
    End point description
    3/6 refers to at least 3 out of the last 6 weeks of the treatment period
    End point type
    Post-hoc
    End point timeframe
    Stool consistency was assessed daily for 12 weeks of treatment and run-out period.
    End point values
    		 IBS-D/ebastine IBS-D/placebo
    Number of subjects analysed
    59
    60
    Units: Subjects
    23
    21
    Statistical analysis title
    		 RD - stool consistency responder (3/6)
    Comparison groups
    IBS-D/ebastine v IBS-D/placebo
    Number of subjects included in analysis
    119
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 = 0.651
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.7
         upper limit
    		 20.1

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Every adverse event was reported in the eCRF in a timely manner. In case of a serious adverse event, the coördinating center was informed. In case of AEs leading to death, the ethical committee was also informed.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Ebastine
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Ebastine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 101 (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
    		 Ebastine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 101 (12.87%)
    21 / 101 (20.79%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 101 (2.97%)
    7 / 101 (6.93%)
         occurrences all number
    3
    7
    Immune system disorders
    Allergic reaction
    Additional description: Allergic reaction included skin rash, itching skin or eyes, sneezing and swelling of the throat.
         subjects affected / exposed
    4 / 101 (3.96%)
    5 / 101 (4.95%)
         occurrences all number
    4
    5
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory infection
         subjects affected / exposed
    6 / 101 (5.94%)
    9 / 101 (8.91%)
         occurrences all number
    6
    9

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jul 2014
    Adding an advertisement to share on intranet and the notice boards of KULeuven en UZ Leuven.
    30 Oct 2015
    Informing regional general practitioners and recruiting patients from referral by general practitioners.
    09 Dec 2016
    To evaluate whether inflammatory mediators and/or metabolites in urine have a predictive value regarding therapeutic response, a urine sample was taken before and after treatment with the study medication.
    01 May 2017
    Open-label follow up with treatment of patients with 2x20mg of ebastine. After 8 and 12 weeks of treatment, patients were evaluated.
    22 Jan 2020
    Addition of site: ZNA Middelheim Antwerpen
    22 Jan 2020
    Addition of site: AZ Sint-Maarten

    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/38191268
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