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    Clinical Trial Results:
    A Pharmacokinetic, Pharmacodynamic and Safety Study of Single and Multiple Doses of Rabeprazole in Pediatric Subjects with Gastroesophageal Reflux Disease (GERD) 1 to 11 Months old, Inclusive

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2008-000452-27
    Trial protocol
    BE   GB  
    Global end of trial date
    29 Feb 2012

    Results information
    Results version number
    v2(current)
    This version publication date
    01 Jul 2016
    First version publication date
    05 Aug 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    RABGRD1003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00747526
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, L.L.C.
    Sponsor organisation address
    920 Route 202, PO Box 300,, Raritan, New Jersey, United States, 08869
    Public contact
    Clinical Registry Group, Clinical Registry Group, +31 71524 21 66, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Janssen-Cilag International NV, Janssen-Cilag International NV, +31 71524 21 66, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000055-PIP01-07
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Feb 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Feb 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this trial is to evaluate the pharmacokinetics, pharmacodynamics (intraesophageal/intragastric pH, clinical global impressions, formulation palatability and GERD daily symptom diary) and safety of Rabeprazole (RAB) after single and multiple daily administration at 2 dose levels in children between the ages of 1 and 11 months (inclusive up to 11 months 29 days), with GERD. As this is an exploratory assessment of the pharmacokinetics, pharmacodynamics and safety of rabeprazole in children, no formal hypothesis testing is applied.
    Protection of trial subjects
    Safety was assessed through monitoring of concomitant therapies and adverse events (AEs) throughout the study; and clinical laboratory testing at baseline and post treatment including hematology, clinical chemistry, and urinalysis assessment. Vital signs, 12-lead electrocardiogram, and physical examination including body weight and length were also performed before and after treatment.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    14 Apr 2008
    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: 3
    Country: Number of subjects enrolled
    Brazil: 6
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    United States: 28
    Worldwide total number of subjects
    49
    EEA total number of subjects
    15
    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)
    49
    Children (2-11 years)
    0
    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
    The study was initiated from 14 April 2008 and completed on 29 February 2012 in which subjects from 5 countries were enrolled.

    Pre-assignment
    Screening details
    A total 49 subjects were enrolled in the study out of these 47 subjects completed the study and 2 subjects withdrew the study.

    Period 1
    Period 1 title
    Open Label Treatment Phase (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Part 1 - Rabeprazole 0.14 milligram per kilogram (mg/kg)
    Arm description
    Subject received Rabeprazole 0.14 milligram/kilogram (mg/kg) of body weight capsule orally.
    Arm type
    Experimental

    Investigational medicinal product name
    Rabeprazole Sodium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received Rabeprazole 0.14 milligram/kilogram (mg/kg) of body weight capsule orally.

    Arm title
    Part 1 - Rabeprazole 0.5 mg/kg
    Arm description
    Subject received Rabeprazole 0.5 mg/kg of body weight capsule orally.
    Arm type
    Experimental

    Investigational medicinal product name
    Rabeprazole Sodium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received Rabeprazole 0.5 mg/kg of body weight capsule orally.

    Arm title
    Part 2 - Rabeprazole 5 mg
    Arm description
    Subject received Rabeprazole 5 mg capsule orally.
    Arm type
    Experimental

    Investigational medicinal product name
    Rabeprazole Sodium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received Rabeprazole 5 mg capsule orally.

    Arm title
    Part 2 - Rabeprazole 10 mg
    Arm description
    Subject received Rabeprazole 10 mg capsule orally.
    Arm type
    Experimental

    Investigational medicinal product name
    Rabeprazole Sodium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received Rabeprazole 10 mg capsule orally.

    Arm title
    Part 2 - Placebo
    Arm description
    Subject received the Placebo matching with Rabeprazole.
    Arm type
    other

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received the matched modal dose of Placebo

    Arm title
    Part 2 - Placebo + Rabeprazole 5 mg
    Arm description
    Subject received oral capsule of Placebo in combination with Rabeprazole 5 mg capsule orally.
    Arm type
    Experimental

    Investigational medicinal product name
    Rabeprazole Sodium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received orally Rabeprazole 5 mg capsule orally.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received matched dose of oral capsule of Placebo

    Number of subjects in period 1
    Part 1 - Rabeprazole 0.14 milligram per kilogram (mg/kg) Part 1 - Rabeprazole 0.5 mg/kg Part 2 - Rabeprazole 5 mg Part 2 - Rabeprazole 10 mg Part 2 - Placebo Part 2 - Placebo + Rabeprazole 5 mg
    Started
    2
    10
    9
    9
    18
    1
    Completed
    2
    10
    9
    9
    16
    1
    Not completed
    0
    0
    0
    0
    2
    0
         Lack of efficacy
    -
    -
    -
    -
    1
    -
         Adverse event, serious non-fatal
    -
    -
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1 - Rabeprazole 0.14 milligram per kilogram (mg/kg)
    Reporting group description
    Subject received Rabeprazole 0.14 milligram/kilogram (mg/kg) of body weight capsule orally.

    Reporting group title
    Part 1 - Rabeprazole 0.5 mg/kg
    Reporting group description
    Subject received Rabeprazole 0.5 mg/kg of body weight capsule orally.

    Reporting group title
    Part 2 - Rabeprazole 5 mg
    Reporting group description
    Subject received Rabeprazole 5 mg capsule orally.

    Reporting group title
    Part 2 - Rabeprazole 10 mg
    Reporting group description
    Subject received Rabeprazole 10 mg capsule orally.

    Reporting group title
    Part 2 - Placebo
    Reporting group description
    Subject received the Placebo matching with Rabeprazole.

    Reporting group title
    Part 2 - Placebo + Rabeprazole 5 mg
    Reporting group description
    Subject received oral capsule of Placebo in combination with Rabeprazole 5 mg capsule orally.

    Reporting group values
    Part 1 - Rabeprazole 0.14 milligram per kilogram (mg/kg) Part 1 - Rabeprazole 0.5 mg/kg Part 2 - Rabeprazole 5 mg Part 2 - Rabeprazole 10 mg Part 2 - Placebo Part 2 - Placebo + Rabeprazole 5 mg Total
    Number of subjects
    2 10 9 9 18 1 49
    Title for AgeCategorical
    Units: subjects
        Infants and Toddlers (28 days - 23 months)
    2 10 9 9 18 1 49
    Title for AgeContinuous
    Units: months
        arithmetic mean (standard deviation)
    5 ± 4.24 6.5 ± 2.55 5.6 ± 3.13 4.4 ± 2.83 4.8 ± 2.73 1 ± 0 -
    Title for Gender
    Units: subjects
        Female
    0 7 3 3 8 1 22
        Male
    2 3 6 6 10 0 27

    End points

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    End points reporting groups
    Reporting group title
    Part 1 - Rabeprazole 0.14 milligram per kilogram (mg/kg)
    Reporting group description
    Subject received Rabeprazole 0.14 milligram/kilogram (mg/kg) of body weight capsule orally.

    Reporting group title
    Part 1 - Rabeprazole 0.5 mg/kg
    Reporting group description
    Subject received Rabeprazole 0.5 mg/kg of body weight capsule orally.

    Reporting group title
    Part 2 - Rabeprazole 5 mg
    Reporting group description
    Subject received Rabeprazole 5 mg capsule orally.

    Reporting group title
    Part 2 - Rabeprazole 10 mg
    Reporting group description
    Subject received Rabeprazole 10 mg capsule orally.

    Reporting group title
    Part 2 - Placebo
    Reporting group description
    Subject received the Placebo matching with Rabeprazole.

    Reporting group title
    Part 2 - Placebo + Rabeprazole 5 mg
    Reporting group description
    Subject received oral capsule of Placebo in combination with Rabeprazole 5 mg capsule orally.

    Subject analysis set title
    Safety Analysis Population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All subjects who were randomized and received at least 1 dose of study drug.

    Subject analysis set title
    Pharmacodynamic Analysis Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    All subjects who were randomized, received study drug, and had at least one PD measurement.

    Subject analysis set title
    pH Analysis Set
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    All subjects who were randomized, received study drug, and had pH measurements for at least one day.

    Primary: Maximum Observed Plasma Concentration (Cmax)

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    End point title
    Maximum Observed Plasma Concentration (Cmax) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline up to day 5
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    Part 1 - Rabeprazole 0.14 milligram per kilogram (mg/kg) Part 1 - Rabeprazole 0.5 mg/kg Part 2 - Rabeprazole 5 mg Part 2 - Rabeprazole 10 mg Part 2 - Placebo Part 2 - Placebo + Rabeprazole 5 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    0 [7]
    Units: nanogram per milliliter (ng/ml)
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    ±
    Notes
    [2] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    [3] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    [4] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    [5] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    [6] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    [7] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    No statistical analyses for this end point

    Primary: Time to Reach Maximum Observed Plasma Concentration (Tmax)

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    End point title
    Time to Reach Maximum Observed Plasma Concentration (Tmax) [8]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline up to Day 5
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    Part 1 - Rabeprazole 0.14 milligram per kilogram (mg/kg) Part 1 - Rabeprazole 0.5 mg/kg Part 2 - Rabeprazole 5 mg Part 2 - Rabeprazole 10 mg Part 2 - Placebo Part 2 - Placebo + Rabeprazole 5 mg
    Number of subjects analysed
    0 [9]
    0 [10]
    0 [11]
    0 [12]
    0 [13]
    0 [14]
    Units: Hours
        median (full range (min-max))
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [9] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    [10] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    [11] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    [12] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    [13] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    [14] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    No statistical analyses for this end point

    Primary: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Rabeprezole

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    End point title
    Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Rabeprezole [15]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 and Day 5
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    Part 1 - Rabeprazole 0.14 milligram per kilogram (mg/kg) Part 1 - Rabeprazole 0.5 mg/kg Part 2 - Rabeprazole 5 mg Part 2 - Rabeprazole 10 mg Part 2 - Placebo Part 2 - Placebo + Rabeprazole 5 mg
    Number of subjects analysed
    0 [16]
    0 [17]
    0 [18]
    0 [19]
    0 [20]
    0 [21]
    Units: nanogram*hour per milliliter
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    ±
    Notes
    [16] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    [17] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    [18] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    [19] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    [20] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    [21] - No descriptive statistics of pharmacokinetic data was performed due to small number of subjects.
    No statistical analyses for this end point

    Primary: Percentage Duration With An Intragastric pH

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    End point title
    Percentage Duration With An Intragastric pH [22]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 and Day 5
    Notes
    [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    pH Analysis Set
    Number of subjects analysed
    15 [23]
    Units: Percentage of Time in a 24 Hour Period
    arithmetic mean (standard deviation)
        Day 1: Intragastric pH<4
    69.894 ± 28.5873
        Day 5: Intragastric pH<4
    68.49 ± 26.056
        Day 1: Intragastric pH<3
    60.84 ± 57.367
        Day 5: Intragastric pH<5
    28.7609 ± 24.9894
    Notes
    [23] - pH analysis set.
    No statistical analyses for this end point

    Primary: Percentage Duration With An Intraesophageal pH

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    End point title
    Percentage Duration With An Intraesophageal pH [24]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 and Day 5
    Notes
    [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    pH Analysis Set
    Number of subjects analysed
    15
    Units: Percentage of Time in a 24 Hour Period
    arithmetic mean (standard deviation)
        Day 1
    12.853 ± 19.3117
        Day 5
    10.027 ± 20.9011
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Clinical Global Impression Severity (CGI-S) Score  

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    End point title
    Percentage of Subjects With Clinical Global Impression Severity (CGI-S) Score   [25]
    End point description
    The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point (1-absent, 2-minimal, 3-mild, 4-moderate, 5-moderate severe, 6-severe, 7-extreme) global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "normal, not at all ill" and a rating of 7 is equivalent to "among the most extremely ill participants". Higher scores indicate worsening.
    End point type
    Primary
    End point timeframe
    At Baseline
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    Part 1 - Rabeprazole 0.14 milligram per kilogram (mg/kg) Part 1 - Rabeprazole 0.5 mg/kg Part 2 - Rabeprazole 5 mg Part 2 - Rabeprazole 10 mg Part 2 - Placebo Part 2 - Placebo + Rabeprazole 5 mg
    Number of subjects analysed
    2
    10
    9
    9
    18
    1
    Units: Percentage of Subjects
    number (not applicable)
        Normal, not at all ill
    1
    1
    0
    0
    3
    0
        Borderline ill
    0
    1
    0
    1
    5
    0
        Mildly ill
    0
    0
    3
    4
    2
    0
        Moderately ill
    1
    5
    4
    2
    5
    0
        Markedly ill
    0
    3
    0
    2
    3
    1
        Severely ill
    0
    0
    2
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)

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    End point title
    Percentage of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) [26]
    End point description
    The Clinical Global Impression (CGI) rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant, which ranges from "very much worse" to "very much improved".
    End point type
    Primary
    End point timeframe
    End of study
    Notes
    [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    Part 1 - Rabeprazole 0.14 milligram per kilogram (mg/kg) Part 1 - Rabeprazole 0.5 mg/kg Part 2 - Rabeprazole 5 mg Part 2 - Rabeprazole 10 mg Part 2 - Placebo Part 2 - Placebo + Rabeprazole 5 mg
    Number of subjects analysed
    2
    10
    9
    9
    18
    1
    Units: Percentage of Subjects
    number (not applicable)
        Much improved
    0
    0
    0
    0
    1
    1
        Minimally improved
    0
    0
    0
    1
    0
    0
        No change
    1
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with the Palatability Scores on Day 1 and Day 5

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    End point title
    Number of subjects with the Palatability Scores on Day 1 and Day 5 [27]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 and Day 5
    Notes
    [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    Number of subjects analysed
    Units: Percentage of Subjects
    number (not applicable)
        Day 1: Poor
        Day 1: Fair
        Day 1: Good
        Day 1: Excellent
        Day 5: Poor
        Day 5: Fair
        Day 5: Good
        Day 5: Excellent
    No statistical analyses for this end point

    Primary: Change From Baseline in the Total gastroesophageal reflux disease (GERD) Symptom and Severity Score at Day 5

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    End point title
    Change From Baseline in the Total gastroesophageal reflux disease (GERD) Symptom and Severity Score at Day 5 [28]
    End point description
    The gastroesophageal reflux disease (GERD) symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening, while a negative score indicates improvement.
    End point type
    Primary
    End point timeframe
    Day 1 and Day 5
    Notes
    [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    Pharmacodynamic Analysis Population
    Number of subjects analysed
    49
    Units: units on a scale
    arithmetic mean (standard deviation)
        Day 1: Times baby regurgitate
    2.55 ± 3.156
        Day 5: Times baby regurgitate
    2.35 ± 3.035
        Day 1: Hours or minutes baby cry or fuss
    1.28 ± 2.03
        Day 5: Hours or minutes baby cry or fuss
    0.88 ± 1.658
        Day 1: Times baby have episodes or arching back
    1.86 ± 3.397
        Day 5: Times baby have episodes or arching back
    1.17 ± 2.461
        Day 1: Times baby cry during a feeding
    0.69 ± 1.262
        Day 5: Times baby cry during a feeding
    0.29 ± 0.617
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to end of study
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Part 1 - Rabeprazole 0.14 milligram per kilogram (mg/kg)
    Reporting group description
    Subject received Rabeprazole 0.14 milligram/kilogram (mg/kg) of body weight capsule orally.

    Reporting group title
    Part 1 - Rabeprazole 0.5 mg/kg
    Reporting group description
    Subject received Rabeprazole 0.5 mg/kg of body weight capsule orally.

    Reporting group title
    Part 2 - Placebo
    Reporting group description
    Subject received the Placebo matching with Rabeprazole.

    Reporting group title
    Part 2 - Rabeprazole 10 mg
    Reporting group description
    Subject received Rabeprazole 10 mg capsule orally.

    Reporting group title
    Part 2 - Placebo + Rabeprazole 5 mg
    Reporting group description
    Subject received oral capsule of Placebo in combination with Rabeprazole 5 mg capsule orally.

    Reporting group title
    Part 2 - Rabeprazole 5 mg
    Reporting group description
    Subject received Rabeprazole 5 mg capsule orally.

    Serious adverse events
    Part 1 - Rabeprazole 0.14 milligram per kilogram (mg/kg) Part 1 - Rabeprazole 0.5 mg/kg Part 2 - Placebo Part 2 - Rabeprazole 10 mg Part 2 - Placebo + Rabeprazole 5 mg Part 2 - Rabeprazole 5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 10 (0.00%)
    2 / 18 (11.11%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    1 / 9 (11.11%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Feeding Disorder
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Respiratory Syncytial Virus Bronchiolitis
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Part 1 - Rabeprazole 0.14 milligram per kilogram (mg/kg) Part 1 - Rabeprazole 0.5 mg/kg Part 2 - Placebo Part 2 - Rabeprazole 10 mg Part 2 - Placebo + Rabeprazole 5 mg Part 2 - Rabeprazole 5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    6 / 10 (60.00%)
    8 / 18 (44.44%)
    3 / 9 (33.33%)
    0 / 1 (0.00%)
    4 / 9 (44.44%)
    Investigations
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Blood Gastrin Increased
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
    2 / 9 (22.22%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Cardiac Murmur
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Platelet Count Increased
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Cardiac disorders
    Cyanosis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
    1 / 9 (11.11%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    2 / 18 (11.11%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Nasal Obstruction
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Rhinitis Allergic
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Eye disorders
    Eye Discharge
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Eye Swelling
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Mass
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 10 (10.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 2 (0.00%)
    2 / 10 (20.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    0
    Haematemesis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
    1 / 9 (11.11%)
    0 / 1 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Rash Maculo-Papular
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Diarrhoea Infectious
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 2 (0.00%)
    2 / 10 (20.00%)
    0 / 18 (0.00%)
    1 / 9 (11.11%)
    0 / 1 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    2
    0
    1
    0
    1
    Nosocomial Infection
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Otitis Media
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 10 (10.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jun 2007
    Amendment INT-1 was implemented and included the following changes: a) The enrollment weight specified as minimum weight of 5 kg in pediatric subjects; b) Changes in PK sampling schedule; adjustments in collected blood volume; c) Changes to some assessments in Time and Events schedule; and d) Fasting gastrin sample collection moved from screening visit to predose on Day 1.
    02 Jan 2008
    Amendment INT-2 was implemented and included the change in order to facilitate enrollment, the overnight stay requirement was removed for subjects not enrolled in the pH probe component of the study.
    19 Sep 2008
    Amendment INT-3 was implemented after the enrollment of 2 subjects and included the changes: a) of dose in Part 1 of the study was increased from 0.14 mg/kg to 0.5 mg/kg; b) In order to facilitate enrollment, subjects were given 2 treatment options (Option 1 with treatment for 5 days and semi-rich PK sampling schedule; Option 2 with treatment up to 14 days and sparse PK sampling) and a lower minimum weight was allowed for one of these treatment options. The total study period was updated for consistency with new treatment options; c) Adjustments in collected blood volume were made; and c) Exclusion criteria were updated.
    17 Sep 2009
    Amendment INT-4 was implemented after the enrollment of 11 subjects and included the following changes: a) The total number of subjects planned to be enrolled in Part 1 of the study was reduced from 12 to 9, as data from Part 1 was used to select doses in Part 2; b) Doses used in Part 2 were defined; dosing instructions for Part 2 were added; c) Subjects enrolled in Part 1 were allowed to be enrolled in Part 2; and d) Participation in the pharmacogenomic research portion was made optional.
    10 Nov 2009
    Amendment INT-5 was implemented after the enrollment of 11 subjects and included the following change of Volume of blood collection was reduced.
    22 Oct 2010
    Amendment INT-6 was implemented after the enrollment of 34 subjects and included the following changes: a) Rationale for commissioning of DMSB was added; b) Guidance was provided regarding dosing in case subjects vomited after drug intake; c) Clarification was made regarding the type of PK analysis to be done; clarification was added regarding PK sample processing; d) Instructions were added to allow pH monitoring at home and additional clarification was provided on pH monitoring; e) Specification on minimum number of subjects was added; and f) A statement was added indicating that the use of PPIs, H2-blockers, antacids and sucralfate was allowed during follow up phase after collection of the last PK sample and discontinuation of study drug administration.
    08 Feb 2011
    Amendment INT-7 was implemented after the enrollment of 35 subjects and included the following change of Capillary sampling for PK samples was allowed.
    18 May 2011
    Amendment INT-8 was implemented after the enrollment of 37 subjects and included the following change: a) The dosing duration in Part 2 of the study was increased from up to 14 days to a maximum of 28 days. A total duration of study for subjects enrolled in Part 2 of 9 weeks was added.
    24 Aug 2011
    Amendment INT-9 was implemented after the enrollment of 42 subjects and included the following change of Capillary sampling for clinical laboratory samples was allowed.

    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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