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    Clinical Trial Results:
    A Pharmacokinetic and Safety Study of Single and Multiple Doses of Rabeprazole in Pediatric Subjects with Gastroesophageal reflux disease (GERD) 1 to 11 Years old, inclusive

    Summary
    EudraCT number
    		 2008-000451-97
    Trial protocol
    		 BE  
    Global end of trial date
    16 Sep 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jul 2016
    First version publication date
    01 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RABGRD1002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00747695
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Johnson & Johnson Pharmaceutical Research & Development, LLC
    Sponsor organisation address
    920 US Route 202 Raritan, New Jersey, United States,
    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)
    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
    16 Sep 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Sep 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the study was to evaluate the pharmacokinetics (PK), pharmacodynamics (PD, clinical global impressions [CGI] and formulation palatability) and safety of rabeprazole after single and multiple daily administration at 2 dose levels in children between the ages of 1 to 11 years, inclusive (up to 11 years 364 days), with Gastroesophageal Reflux Disease (GERD). As this study 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 evaluations were performed in reference to adverse events, clinical laboratory tests (serum chemistry and hematology), vital signs (blood pressure, pulse, respiratory rate, temperature), electrocardiogram (ECG) and physical examinations including height/length and body weight was conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Mar 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
    United States: 25
    Worldwide total number of subjects
    28
    EEA total number of subjects
    3
    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)
    28
    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
    		 Total 28 subjects were enrolled in the study, out of which 27 subjects completed the study.

    Pre-assignment
    Screening details
    		 Screening of up to 21 days was done in which medical history and evaluation of symptoms were recorded before the beginning of treatment.

    Period 1
    Period 1 title
    Overall Study (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
    		 Rabeprazole 0.14 milligram per kilogram (mg/kg)
    Arm description
    		 Subjects received rabeprazole sodium 0.14 mg/kg of body weight as single daily oral doses for 5 successive days as a bead formulation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rabeprazole Sodium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received rabeprazole sodium 0.14 mg/kg as single daily oral doses for 5 successive days as a bead formulation.

    Arm title
    		 Rabeprazole 1.0 mg/kg
    Arm description
    		 Subjects received rabeprazole sodium 1.0 mg/kg as single daily oral doses for 5 successive days as a bead formulation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rabeprazole Sodium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received rabeprazole sodium 1.0 mg/kg as single daily oral doses for 5 successive days as a bead formulation.

    Arm title
    		 Rabeprazole 0.5 mg/kg
    Arm description
    		 Subjects received rabeprazole sodium 0.5 mg/kg as single daily oral doses for 5 successive days as a bead formulation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rabeprazole Sodium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received rabeprazole sodium 0.5 mg/kg as single daily oral doses for 5 successive days as a bead formulation.

    Number of subjects in period 1
    		Rabeprazole 0.14 milligram per kilogram (mg/kg) Rabeprazole 1.0 mg/kg Rabeprazole 0.5 mg/kg
    Started
    8
    9
    11
    Completed
    8
    9
    10
    Not completed
    0
    0
    1
         Adverse event, non-fatal
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rabeprazole 0.14 milligram per kilogram (mg/kg)
    Reporting group description
    		 Subjects received rabeprazole sodium 0.14 mg/kg of body weight as single daily oral doses for 5 successive days as a bead formulation.

    Reporting group title
    Rabeprazole 0.5 mg/kg
    Reporting group description
    		 Subjects received rabeprazole sodium 0.5 mg/kg as single daily oral doses for 5 successive days as a bead formulation.

    Reporting group title
    Rabeprazole 1.0 mg/kg
    Reporting group description
    		 Subjects received rabeprazole sodium 1.0 mg/kg as single daily oral doses for 5 successive days as a bead formulation.

    Reporting group values
    		 Rabeprazole 0.14 milligram per kilogram (mg/kg) Rabeprazole 0.5 mg/kg Rabeprazole 1.0 mg/kg Total
    Number of subjects
    		 8 11 9 28
    Title for AgeCategorical
    Units: subjects
        Children (1-11 years)
    		 8 11 9 28
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65 to 84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.5 ( 3.74 ) 6.6 ( 3.85 ) 6.1 ( 3.86 ) -
    Title for Gender
    Units: subjects
        Female
    		 3 4 5 12
        Male
    		 5 7 4 16

    End points

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    End points reporting groups
    Reporting group title
    Rabeprazole 0.14 milligram per kilogram (mg/kg)
    Reporting group description
    		 Subjects received rabeprazole sodium 0.14 mg/kg of body weight as single daily oral doses for 5 successive days as a bead formulation.

    Reporting group title
    Rabeprazole 1.0 mg/kg
    Reporting group description
    		 Subjects received rabeprazole sodium 1.0 mg/kg as single daily oral doses for 5 successive days as a bead formulation.

    Reporting group title
    Rabeprazole 0.5 mg/kg
    Reporting group description
    		 Subjects received rabeprazole sodium 0.5 mg/kg as single daily oral doses for 5 successive days as a bead formulation.

    Primary: Maximum Observed Plasma Concentration (Cmax) of Rabeprazole

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Rabeprazole [1]
    End point description
    The Cmax is the maximum observed plasma concentration. Here 'n' is equal to number of subjects analyzed for this endpoint at specific time point.
    End point type
    Primary
    End point timeframe
    Day 1 and 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: Statistical analysis were not planned to be reported.
    End point values
    		 Rabeprazole 0.14 milligram per kilogram (mg/kg) Rabeprazole 0.5 mg/kg Rabeprazole 1.0 mg/kg
    Number of subjects analysed
    8 [2]
    10 [3]
    9 [4]
    Units: Nanogram per millilitre (ng/ml)
    arithmetic mean (full range (min-max))
        Day 1 (n=7, 10, 7)
    2 (1 to 6)
    2 (1 to 5.98)
    2 (1 to 4)
        Day 5 (n=8, 10, 9)
    2 (1 to 4)
    1.53 (1 to 2.08)
    2 (0.68 to 4)
    Notes
    [2] - Pharmacokinetic Analysis Set
    [3] - Pharmacokinetic Analysis Set
    [4] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of Rabeprazole

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of Rabeprazole [5]
    End point description
    AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. Here 'n' is equal to number of subjects analyzed for this endpoint at specific time point.
    End point type
    Primary
    End point timeframe
    Day 1 and 5
    Notes
    [5] - 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: Statistical analysis were not planned to be reported.
    End point values
    		 Rabeprazole 0.14 milligram per kilogram (mg/kg) Rabeprazole 0.5 mg/kg Rabeprazole 1.0 mg/kg
    Number of subjects analysed
    8 [6]
    10 [7]
    9 [8]
    Units: hour*nanogram per millilitre (h.ng/ml)
    arithmetic mean (standard deviation)
        Day 1 (n=3, 9, 7)
    169 ( 98.4 )
    309 ( 78.2 )
    694 ( 519 )
        Day 5 (n=4, 9, 9)
    142 ( 57.6 )
    419 ( 234 )
    869 ( 579 )
    Notes
    [6] - Pharmacokinetic Analysis Set
    [7] - Pharmacokinetic Analysis Set
    [8] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Sampling Point (i.e, 12 Hours)of Rabeprazole

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Sampling Point (i.e, 12 Hours)of Rabeprazole [9]
    End point description
    AUCall is the Area under the plasma concentration-time curve from time 0 to the last sampling point (i.e. 12 hours). Here 'n' is equal to number of subjects analyzed for this endpoint at specific time point.
    End point type
    Primary
    End point timeframe
    Day 1 and 5
    Notes
    [9] - 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: Statistical analysis were not planned to be reported.
    End point values
    		 Rabeprazole 0.14 milligram per kilogram (mg/kg) Rabeprazole 0.5 mg/kg Rabeprazole 1.0 mg/kg
    Number of subjects analysed
    8 [10]
    10 [11]
    9 [12]
    Units: h.ng/ml
    arithmetic mean (standard deviation)
        Day 1 (n=3, 5, 7)
    181 ( 101 )
    337 ( 94.1 )
    716 ( 505 )
        Day 5 (n=4, 9, 9)
    157 ( 50.4 )
    429 ( 232 )
    884 ( 579 )
    Notes
    [10] - Pharmacokinetic Analysis Set
    [11] - Pharmacokinetic Analysis Set
    [12] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite [13]
    End point description
    The AUC (0 - infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z). Here 'n' is equal to number of subjects analyzed for this endpoint at specific time point. Standard deviation (SD) for group rabeprazole 0.14 mg/kg was not estimable because only subject was analyzed at day 1 for this end point. Therefore, value mentioned for SD i.e. 99999= NA (Not Applicable). Similarly mean value for group rabeprazole 0.14 mg/kg at day 5 i.e. 999= 185, 224 because only two subjects was analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    Day 1 and 5
    Notes
    [13] - 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: Statistical analysis were not planned to be reported.
    End point values
    		 Rabeprazole 0.14 milligram per kilogram (mg/kg) Rabeprazole 0.5 mg/kg Rabeprazole 1.0 mg/kg
    Number of subjects analysed
    8 [14]
    10 [15]
    9 [16]
    Units: h.ng/mL
    arithmetic mean (standard deviation)
        Day 1(n=1, 5, 6)
    261 ( 99999 )
    346 ( 77.9 )
    785 ( 526 )
        Day 5(n=2, 6, 7)
    999 ( 21.6 )
    490 ( 263 )
    936 ( 600 )
    Notes
    [14] - Pharmacokinetic Analysis Set
    [15] - Pharmacokinetic Analysis Set
    [16] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Plasma Decay Half-Life (t1/2) of Rabeprazole

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    End point title
    		 Plasma Decay Half-Life (t1/2) of Rabeprazole [17]
    End point description
    The t1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). Here 'n' is equal to number of subjects analyzed for this endpoint at specific time point. Standard deviation (SD) for group rabeprazole 0.14 mg/kg was not estimable because only subject was analyzed at day 1 and 2 subjects at day 5 for this end point. Therefore, value mentioned for SD i.e. 99999= NA (Not Applicable). Similarly mean value for group rabeprazole 0.14 mg/kg at day 5 i.e. 999= 1.2, 1.4 because only two subjects was analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    Day 1 and 5
    Notes
    [17] - 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: Statistical analysis were not planned to be reported.
    End point values
    		 Rabeprazole 0.14 milligram per kilogram (mg/kg) Rabeprazole 0.5 mg/kg Rabeprazole 1.0 mg/kg
    Number of subjects analysed
    8 [18]
    10 [19]
    9 [20]
    Units: hour
    arithmetic mean (standard deviation)
        Day 1(n=1, 5, 6)
    1.3 ( 99999 )
    1.3 ( 0.4 )
    1.9 ( 1 )
        Day 5(n=2, 6, 7)
    999 ( 99999 )
    1.1 ( 0.4 )
    1.2 ( 0.6 )
    Notes
    [18] - Pharmacokinetic Analysis Set
    [19] - Pharmacokinetic Analysis Set
    [20] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Ratio of AUCall values on Day 5 versus Day 1 of Rabeprazole

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    End point title
    		 Ratio of AUCall values on Day 5 versus Day 1 of Rabeprazole [21]
    End point description
    AURACall calculated as the ratio of AUCall values on Day 5 versus Day 1 for each subject. Here 'n' is equal to number of subjects analyzed for this endpoint at specific time point. Mean value and standard deviation (SD) for groups rabeprazole 0.14 mg/kg, 0.5 mg/kg and 1 mg/kg were not estimable because zero subject was analyzed at day 1 for this end point. Therefore, value mentioned for mean i.e. 999 and SD i.e. 99999= NA (Not Applicable).
    End point type
    Primary
    End point timeframe
    Day 1 and 5
    Notes
    [21] - 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: Statistical analysis were not planned to be reported.
    End point values
    		 Rabeprazole 0.14 milligram per kilogram (mg/kg) Rabeprazole 0.5 mg/kg Rabeprazole 1.0 mg/kg
    Number of subjects analysed
    8 [22]
    10 [23]
    9 [24]
    Units: h.ng/mL
    arithmetic mean (standard deviation)
        Day 1(n=0, 0, 0)
    999 ( 99999 )
    999 ( 99999 )
    999 ( 99999 )
        Day 5(n=3, 7, 7)
    1.23 ( 0.69 )
    1.16 ( 0.49 )
    1.39 ( 0.83 )
    Notes
    [22] - Pharmacokinetic Analysis Set
    [23] - Pharmacokinetic Analysis Set
    [24] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Secondary: Percentage of Subject with Clinical Global Impression - Severity of Illness Subscale (CGI-S)

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    End point title
    		 Percentage of Subject with Clinical Global Impression - Severity of Illness Subscale (CGI-S)
    End point description
    The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point 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
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Rabeprazole 0.14 milligram per kilogram (mg/kg) Rabeprazole 0.5 mg/kg Rabeprazole 1.0 mg/kg
    Number of subjects analysed
    8
    11
    9
    Units: Percentage of Subjects
    number (not applicable)
        Mildly ill
    5
    6
    5
        Moderately ill
    3
    4
    2
    No statistical analyses for this end point

    Secondary: Percentage of Subject with Clinical Global Impression - Global

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    End point title
    		 Percentage of Subject with Clinical Global Impression - Global
    End point description
    The Clinical Global Impression-Change (CGI-C) rating scale is used to rate the change in severity of the Participant's illness compared to baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
    End point type
    Secondary
    End point timeframe
    End of Study or Early Withdrawal
    End point values
    		 Rabeprazole 0.14 milligram per kilogram (mg/kg) Rabeprazole 0.5 mg/kg Rabeprazole 1.0 mg/kg
    Number of subjects analysed
    8
    11
    9
    Units: Percentage of subjects
    number (not applicable)
        Very much improved
    2
    2
    0
        Much improved
    4
    7
    6
        Minimally improved
    1
    1
    2
        No change
    0
    1
    1
        Minimally worse
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subject with Global assessment of effectiveness

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    End point title
    		 Percentage of Subject with Global assessment of effectiveness
    End point description
    End point type
    Secondary
    End point timeframe
    End of study of Early Withdrawal
    End point values
    		 Rabeprazole 0.14 milligram per kilogram (mg/kg) Rabeprazole 0.5 mg/kg Rabeprazole 1.0 mg/kg
    Number of subjects analysed
    8
    11
    9
    Units: Percentage of subjects
    number (not applicable)
        Poor
    1
    0
    0
        Fair
    0
    2
    0
        Good
    3
    6
    6
        Excellent
    4
    3
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects who found Palatibilty of Drug Good of Excellent

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    End point title
    		 Number of Subjects who found Palatibilty of Drug Good of Excellent
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1, 2, 3, 4, and 5
    End point values
    		 Rabeprazole 0.14 milligram per kilogram (mg/kg) Rabeprazole 0.5 mg/kg Rabeprazole 1.0 mg/kg
    Number of subjects analysed
    8
    11
    9
    Units: Number of Subject
    number (not applicable)
        Day 1: Good
    5
    2
    3
        Day 1: Excellent
    1
    4
    4
        Day 2: Good
    7
    2
    4
        Day 2: Excellent
    1
    4
    4
        Day 3: Good
    3
    2
    4
        Day 3: Excellent
    3
    4
    5
        Day 4: Good
    5
    2
    3
        Day 4: Excellent
    2
    4
    5
        Day 5: Good
    4
    3
    4
        Day 5: Excellent
    3
    4
    5
    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 (Day 5)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Rabeprazole 0.14 mg/kg
    Reporting group description
    		 Subjects received rabeprazole sodium 0.14 mg/kg of body weight as single daily oral doses for 5 successive days as a bead formulation.

    Reporting group title
    Rabeprazole 1.0 mg/kg
    Reporting group description
    		 Subjects received rabeprazole sodium 1.0 mg/kg as single daily oral doses for 5 successive days as a bead formulation.

    Reporting group title
    Rabeprazole 0.5 mg/kg
    Reporting group description
    		 Subjects received rabeprazole sodium 0.5 mg/kg as single daily oral doses for 5 successive days as a bead formulation.

    Serious adverse events
    		 Rabeprazole 0.14 mg/kg Rabeprazole 1.0 mg/kg Rabeprazole 0.5 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Volvulus
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Rabeprazole 0.14 mg/kg Rabeprazole 1.0 mg/kg Rabeprazole 0.5 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 8 (62.50%)
    7 / 9 (77.78%)
    9 / 11 (81.82%)
    Investigations
    Blood Gastrin Increased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    0
    1
    Blood Uric Acid Increased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Haemoglobin Decreased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac Murmur
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Arthropod Bite
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Excoriation
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Presyncope
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 9 (22.22%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    0
    Ear and labyrinth disorders
    Ear Pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    4
    0
    0
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Hypergastrinaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    1
    Nausea
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Pancreatitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Regurgitation
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Toothache
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    3 / 11 (27.27%)
         occurrences all number
    0
    0
    3
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Cough
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 9 (22.22%)
    1 / 11 (9.09%)
         occurrences all number
    0
    2
    1
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    1
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Gastritis Viral
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Pharyngitis Streptococcal
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Hypernatraemia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Oct 2007
    The following major changes were made in the first amendment of protocol: Paper CRF was replaced by eCRF as data were collected electronically. Correction was made to indicate the randomization system. The time and events schedule was updated to reflect changes in PK sample collection, fasting gastrin, and screening physical examination and ECG collection. Total blood volume to be collected was updated. The minimum body weight for enrollment was updated. Updated to indicate the correct laboratory.
    02 Jan 2008
    The second amendment was released in order to facilitate enrollment, the requirement for an overnight stay at the study center was made optional.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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