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    Clinical Trial Results:
    A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Prospective Study to Evaluate the Safety and Efficacy of Domperidone in 6-month-old to 12-year-old Pediatric Subjects With Nausea and Vomiting Due to Acute Gastroenteritis

    Summary
    EudraCT number
    		 2015-002923-24
    Trial protocol
    		 GB   PT   BE   ES   AT   IT  
    Global end of trial date
    03 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2018
    First version publication date
    16 Feb 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    R033812GTS3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02699385
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Archimedesweg 29, Leiden, Netherlands, 2333 CM
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    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 Aug 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Aug 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the study was to demonstrate that domperidone suspension (1 milligram per milliliter [mg/mL]) plus oral rehydration treatment (ORT) was more effective than placebo plus ORT at reducing the symptoms of vomiting associated with acute gastroenteritis (AG) within the first 48 hours of treatment administration in pediatric subjects aged 6 months to 12 years with AG and mild-to-moderate dehydration.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice and applicable regulatory requirements and also known instances of nonconformance were documented and are not considered to have had an impact on the overall conclusions of this study. Safety included incidence, and assessment of adverse events (AEs) vital sign measurements, physical examinations, adverse events of special interest (AESIs) that were referred to as adverse events (AEs) of clinical interest in the data outputs.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jul 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 11
    Country: Number of subjects enrolled
    Belgium: 15
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Russian Federation: 200
    Country: Number of subjects enrolled
    South Africa: 35
    Worldwide total number of subjects
    292
    EEA total number of subjects
    57
    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)
    36
    Children (2-11 years)
    256
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 480 pediatric subjects planned for the study,240 subjects were to be randomly assigned in 1:1 ratio to each treatment group (domperidone and placebo). Screening for eligible subjects was performed on the same day as administration of the study agent.

    Period 1
    Period 1 title
    Overall Study (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
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo oral suspension plus Oral rehydration therapy (ORT) if needed (day 2 to 7 thrice daily for up to 7 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo oral suspension plus Oral rehydration therapy (ORT) if needed (day 2 to 7) thrice daily for up to 7 days.

    Investigational medicinal product name
    Oral rehydration therapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Oral rehydration therapy (ORT) thrice daily for up to 7 days.

    Arm title
    		 Domperidone
    Arm description
    		 Subjects received domperidone suspension (1 milligram(s) per milliliter (mg/mL)) plus ORT if needed (day 2 to 7) thrice daily for up to 7 day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oral rehydration therapy (ORT)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received ORT if needed (day 2 to 7) thrice daily for up to 7 days.

    Investigational medicinal product name
    Domperidone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received domperidone suspension (1 milligram(s) per milliliter [mg/mL]) plus ORT if needed (day 2 to day 7) thrice daily for up to 7 days.

    Number of subjects in period 1
    		Placebo Domperidone
    Started
    145
    147
    Completed
    141
    146
    Not completed
    4
    1
         Adverse event, non-fatal
    2
    1
         Non- specified
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo oral suspension plus Oral rehydration therapy (ORT) if needed (day 2 to 7 thrice daily for up to 7 days.

    Reporting group title
    Domperidone
    Reporting group description
    		 Subjects received domperidone suspension (1 milligram(s) per milliliter (mg/mL)) plus ORT if needed (day 2 to 7) thrice daily for up to 7 day.

    Reporting group values
    		 Placebo Domperidone Total
    Number of subjects
    		 145 147 292
    Title for AgeCategorical
    Units: subjects
        infants and toddlers(6 Months to <4 Years)
    		 18 18 36
        Children (4 to 12 Years)
    		 127 129 256
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65 to 84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 6.766 ( 2.7868 ) 6.964 ( 2.5318 ) -
    Title for Gender
    Units: subjects
        Female
    		 62 74 136
        Male
    		 83 73 156

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo oral suspension plus Oral rehydration therapy (ORT) if needed (day 2 to 7 thrice daily for up to 7 days.

    Reporting group title
    Domperidone
    Reporting group description
    		 Subjects received domperidone suspension (1 milligram(s) per milliliter (mg/mL)) plus ORT if needed (day 2 to 7) thrice daily for up to 7 day.

    Primary: Percentage of Subjects With No Vomiting Episodes Within the First 48 Hours of the First Treatment Administration

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    End point title
    		 Percentage of Subjects With No Vomiting Episodes Within the First 48 Hours of the First Treatment Administration
    End point description
    The vomiting episodes were recorded for each subjects in the eDiary. The Intent-to-Treat (ITT) Analysis Set population included all the randomized subjects.
    End point type
    Primary
    End point timeframe
    48 hours
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    145
    147
    Units: Percentage of subjects
        number (not applicable)
    33.8
    32.0
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Domperidone
    Number of subjects included in analysis
    292
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.732
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of Subjects 4 Years of Age or Older With No Episode of Nausea Within the First 48 Hours of the First Treatment Administration.

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    End point title
    		 Percentage of Subjects 4 Years of Age or Older With No Episode of Nausea Within the First 48 Hours of the First Treatment Administration.
    End point description
    The nausea episodes were recorded in the eDiary. The ITT population included all the randomized subjects. Here 'N' signifies number of subjects who were analyzed for this endpoint.
    End point type
    Secondary
    End point timeframe
    48 hours
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    127
    129
    Units: Percentage of subjects
        number (not applicable)
    38.6
    35.7
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Domperidone
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.617
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Mean Number of Vomiting Episodes for All Subjects Within the 0 to 24 Hour, Greater Than (>) 24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration

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    End point title
    		 Mean Number of Vomiting Episodes for All Subjects Within the 0 to 24 Hour, Greater Than (>) 24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration
    End point description
    The vomiting episodes were recorded for each subjects in the eDiary. The ITT population included all the randomized subjects.
    End point type
    Secondary
    End point timeframe
    Up to Day 7
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    145
    147
    Units: Vomiting episodes
    arithmetic mean (standard deviation)
        0 - <= 24 Hours
    1.6 ( 1.64 )
    1.4 ( 1.35 )
        > 24 - <= 48 Hours
    0.2 ( 0.55 )
    0.1 ( 0.45 )
        > 48 Hours - <= 7 Days
    0.0 ( 0.25 )
    0.1 ( 0.26 )
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Placebo v Domperidone
    Number of subjects included in analysis
    292
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.835
    Method
    		 Generalized linear model
    Confidence interval

    Secondary: Mean Number of Episodes of Nausea for Subjects 4 Years of age or Older Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration

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    End point title
    		 Mean Number of Episodes of Nausea for Subjects 4 Years of age or Older Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration
    End point description
    The nausea episodes were recorded in the eDiary. The ITT population included all the randomized subjects. Here 'N' signifies number of subjects who were analyzed for this endpoint.
    End point type
    Secondary
    End point timeframe
    Up to Day 7
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    127
    129
    Units: Nausea episodes
    arithmetic mean (standard deviation)
        0 - <= 24 Hours
    1.8 ( 2.02 )
    1.5 ( 1.72 )
        > 24 - <= 48 Hours
    0.2 ( 0.58 )
    0.2 ( 0.69 )
        > 48 Hours - <= 7 Days
    0.1 ( 0.67 )
    0.1 ( 0.44 )
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Placebo v Domperidone
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.413
    Method
    		 Generalized linear model
    Confidence interval

    Secondary: Percentage of Subjects who had No Episode of Vomiting Within the 0- to 24-hour, >24 to 48-Hour, and >48-Hour to 7 Day Periods After the First Treatment Administration

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    End point title
    		 Percentage of Subjects who had No Episode of Vomiting Within the 0- to 24-hour, >24 to 48-Hour, and >48-Hour to 7 Day Periods After the First Treatment Administration
    End point description
    The vomiting episodes were recorded for each subjects in the eDiary. The ITT population included as all the randomized subjects.
    End point type
    Secondary
    End point timeframe
    Up to Day 7
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    145
    147
    Units: Percentage of Subjects
    number (not applicable)
        <= 24 Hours
    35.9
    32.7
        > 24 - <= 48 Hours
    86.2
    89.1
        48 Hours - <= 7 Days
    95.2
    95.2
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Placebo v Domperidone
    Number of subjects included in analysis
    292
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.807
    Method
    		 Generalized linear model
    Confidence interval

    Secondary: Percentage of Subjects 4 Years of age or Older who had No Episode of Nausea Within the 0- to 24-Hour, >24 to 48-Hour, and >48-Hour to 7 Day Periods After the First Treatment Administration

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    End point title
    		 Percentage of Subjects 4 Years of age or Older who had No Episode of Nausea Within the 0- to 24-Hour, >24 to 48-Hour, and >48-Hour to 7 Day Periods After the First Treatment Administration
    End point description
    The nausea episodes were recorded in the eDiary. The ITT population included all the randomized subjects. Here 'N' signifies number of subjects who were analyzed for this endpoint.
    End point type
    Secondary
    End point timeframe
    Up to Day 7
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    127
    129
    Units: Percentage of Subjects
    number (not applicable)
        0 - <= 24 Hours;
    40.2
    38.0
        > 24 - <= 48 Hours
    85.8
    85.3
        > 48 Hours - <= 7 Days
    92.9
    96.9
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Placebo v Domperidone
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.235
    Method
    		 Generalized linear model
    Confidence interval

    Secondary: Percentage of Subjects who had No Episode of Vomiting Within the 7 day Treatment Period After the First Treatment Administration

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    End point title
    		 Percentage of Subjects who had No Episode of Vomiting Within the 7 day Treatment Period After the First Treatment Administration
    End point description
    The vomiting episodes were recorded for each subjects in the eDiary. The ITT population included as all the randomized subjects.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 7
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    145
    147
    Units: Percentage of subjects
        number (not applicable)
    32.4
    30.6
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Domperidone
    Number of subjects included in analysis
    292
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.707
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of Subjects 4 Years of age or Older who had no Episode of Nausea Within the 7 day Treatment Period After the First Treatment Administration

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    End point title
    		 Percentage of Subjects 4 Years of age or Older who had no Episode of Nausea Within the 7 day Treatment Period After the First Treatment Administration
    End point description
    The nausea episodes were recorded in the eDiary. The ITT population included all the randomized subjects. Here 'N' signifies number of subjects who were analyzed for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 7
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    127
    129
    Units: Percentage of subjects
        number (not applicable)
    37.8
    35.7
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Domperidone
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.68
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of Subjects Taking a Rescue Medication Within the 7-day Treatment Period

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    End point title
    		 Percentage of Subjects Taking a Rescue Medication Within the 7-day Treatment Period
    End point description
    If nausea, vomiting, or diarrhea worsens during the study and the investigator initiate rescue medication, the study medication discontinued. The ITT population included all the randomized subjects.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 7
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    145
    147
    Units: Percentage of subjects
        number (not applicable)
    1.4
    0.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Stopping Study Agent Early due to Vomiting-Free for 24 Hours Within the 7-day Treatment Period

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    End point title
    		 Percentage of Subjects Stopping Study Agent Early due to Vomiting-Free for 24 Hours Within the 7-day Treatment Period
    End point description
    The vomiting episodes were recorded for each subjects in the eDiary. The ITT population included all the randomized subjects.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 7
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    145
    147
    Units: Percentage of subjects
        number (not applicable)
    97.2
    99.3
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Domperidone
    Number of subjects included in analysis
    292
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.169
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Mean Time to Last Study Agent Within the 7-day Treatment Period

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    End point title
    		 Mean Time to Last Study Agent Within the 7-day Treatment Period
    End point description
    Time taken to administer last study medication were observed. The ITT population included all the randomized subjects.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 7
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    145
    147
    Units: Hours
        arithmetic mean (standard deviation)
    48.302 ( 25.6233 )
    46.440 ( 20.0828 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Domperidone
    Number of subjects included in analysis
    292
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.382
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percentage of Subjects Referred to an Emergency Room/Hospital for Treatment Within the 7 day Treatment Period.

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    End point title
    		 Percentage of Subjects Referred to an Emergency Room/Hospital for Treatment Within the 7 day Treatment Period.
    End point description
    If nausea, vomiting, or diarrhea worsened during the study and admitted the subject to the hospital for IV fluids, the study medication discontinued. The ITT population included all the randomized subjects.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 7
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    145
    147
    Units: Percentage of subjects
        number (not applicable)
    0.7
    0.7
    No statistical analyses for this end point

    Secondary: Mean Time-to-Last Vomiting Within the 7-day Period After the First Treatment Administration

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    End point title
    		 Mean Time-to-Last Vomiting Within the 7-day Period After the First Treatment Administration
    End point description
    The vomiting episodes were recorded for each subjects in the eDiary. The ITT population included all the randomized subjects. Here 'N' signifies number of subjects who were analyzed for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 7
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    97
    102
    Units: Hours
        arithmetic mean (standard deviation)
    16.88 ( 20.739 )
    16.87 ( 25.388 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Domperidone
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.837
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in Hydration Score From Day 1 (Baseline) to day 2

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    End point title
    		 Change in Hydration Score From Day 1 (Baseline) to day 2
    End point description
    The severity of dehydration were assessed using the Dehydration Score Assessment. a Children under 24 month of age with a score range 7 to 10 points have mild dehydration and children with a score range of 11 to 17 points have moderate dehydration (only children under 24 months of age are evaluated for tears). b) Children 24 months of age or older with a score range of 6 to 9 points have mild dehydration and children with a score range of 10 to 15 points have moderate dehydration. and c) Children under 24 months of age with scores of 18 or more and children 24 months of age or older with scores of 16 or more are considered to be severely dehydrated and were excluded from the study. Here 'N' signifies number of subjects who were analyzed for this endpoint. The ITT population included all the randomized subjects.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Day 2
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    145
    146
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -1.1 ( 1.24 )
    -1.1 ( 1.42 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Domperidone
    Number of subjects included in analysis
    291
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.972
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in Weight at day 2

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    End point title
    		 Change From Baseline in Weight at day 2
    End point description
    Weight was measured to the nearest 100 grams in underwear (no diaper/nappy/training pants). The ITT population included all the randomized subjects. Here 'N' signifies number of subjects who were analyzed for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 2
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    142
    146
    Units: Kilogram
        arithmetic mean (standard deviation)
    -0.03 ( 0.227 )
    -0.01 ( 0.197 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Domperidone
    Number of subjects included in analysis
    288
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.372
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percentage of Subjects With Diarrhea Within 0- to 24-Hour, >24- to 48-Hour, >48-Hour to 7 day After the First Successful Treatment Administration

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    End point title
    		 Percentage of Subjects With Diarrhea Within 0- to 24-Hour, >24- to 48-Hour, >48-Hour to 7 day After the First Successful Treatment Administration
    End point description
    The diarrhea episodes were recorded for each subject in the eDiary. The ITT population included all the randomized subjects.
    End point type
    Secondary
    End point timeframe
    Up to Day 7
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    145
    147
    Units: Percentage of subjects
    number (not applicable)
        0 - <= 24 Hours
    72.4
    68.7
        > 24 - <= 48 Hours
    30.3
    30.6
        > 48 Hours - <= 7 Days
    20.0
    17.7
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Domperidone
    Number of subjects included in analysis
    292
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.555
    Method
    		 Generalized linear model
    Confidence interval

    Secondary: Percentage of Subjects With Diarrhea Within 0-Hour to 7-day After the First Successful Treatment Administration

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    End point title
    		 Percentage of Subjects With Diarrhea Within 0-Hour to 7-day After the First Successful Treatment Administration
    End point description
    The diarrhea episodes were recorded for each subject in the eDiary. The ITT population included all the randomized subjects.
    End point type
    Secondary
    End point timeframe
    Up to Day 7
    End point values
    		 Placebo Domperidone
    Number of subjects analysed
    145
    147
    Units: Percentage of subjects
        number (not applicable)
    76.6
    74.1
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Placebo v Domperidone
    Number of subjects included in analysis
    292
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.562
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to Day 15
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Domperidone
    Reporting group description
    		 Subjects received domperidone suspension (1 milligram(s) per milliliter (mg/mL)) plus ORT if needed (day 2 to 7) thrice daily for up to 7 day.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo oral suspension plus Oral rehydration therapy (ORT) if needed (day 2 to 7 thrice daily for up to 7 days.

    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 non-serious adverse events were observed above frequency threshold of 5 % for any arm.
    Serious adverse events
    		 Domperidone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 147 (0.68%)
    1 / 145 (0.69%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Gastroenteritis Salmonella
         subjects affected / exposed
    1 / 147 (0.68%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 147 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Domperidone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 147 (0.00%)
    0 / 145 (0.00%)

    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? Yes
    Date
    Interruption
    Restart date
    03 Aug 2017
    The study was terminated early for futility based on the recommendations of the Independent Data Monitoring Committee following a planned interim analysis performed when half of the planned subjects to be randomized had either completed or dropped out from the study.
    -

    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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