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    Clinical Trial Results:
    A randomised, assessor blind, placebo controlled exploratory study in healthy volunteers, to characterise the acid neutralisation activity of sodium alginate oral suspension in the fasted state, using a custom-designed intragastric and oesophageal pH catheter.

    Summary
    EudraCT number
    2014-003158-15
    Trial protocol
    NL  
    Global end of trial date
    13 Jul 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Sep 2017
    First version publication date
    28 Sep 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GA1406
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Reckitt Benckiser Healthcare (UK) Ltd
    Sponsor organisation address
    Dansom Lane, Hull, United Kingdom, HU8 7DS
    Public contact
    Clinical Research Director, Clinical Research, Reckitt Benckiser Healthcare (UK) Limited, clinicalrequests@rb.com
    Scientific contact
    Clinical Research Director, Clinical Research, Reckitt Benckiser Healthcare (UK) Limited, clinicalrequests@rb.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
    23 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the intragastric acid neutralisation action of sodium alginate oral suspension versus placebo liquid.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) and the ethical principles contained within the Declaration of Helsinki, as referenced in EU Directive 2001 / 20 / EC.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Apr 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This was a single-centre study conducted in Netherlands.

    Pre-assignment
    Screening details
    Subjects enrolled were 20. Group 1 subjects were 6 and Group 2 subjects were 14.

    Period 1
    Period 1 title
    Treatment 1
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Liquid Cohort (Group II): Treatment P
    Arm description
    Placebo Liquid 2 x 10 ml sachets single dose by mouth under fasted condition. Total 14 subjects received Placebo in Period 1 (8 subjects) and Period 2 (6 subjects) with 5 to 14 days washout period between dosing. Two subjects withdrew from the study during washout period.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo Liquid 20 ml sachets single dose by mouth under fasted condition.

    Arm title
    Tablet Cohort (Group I): Treatment B
    Arm description
    2 x Chewable tablets (calcium carbonate 680 mg and magnesium carbonate 80 mg per tablet) single dose by mouth under fasted condition. This was a separate group to assess the suitability of the custom-designed pH catheter and pH monitoring methodology.
    Arm type
    non-comparative

    Investigational medicinal product name
    Chewable tablets (calcium carbonate 680 mg and magnesium carbonate 80 mg)
    Investigational medicinal product code
    Other name
    Rennie Kauwtabletten
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 x Chewable tablets (Calcium Carbonate 680mg and Magnesium Carbonate 80mg per tablet) by mouth.

    Number of subjects in period 1
    Liquid Cohort (Group II): Treatment P Tablet Cohort (Group I): Treatment B
    Started
    14
    6
    Completed
    12
    6
    Not completed
    2
    0
         Consent withdrawn by subject
    2
    -
    Period 2
    Period 2 title
    Treatment 2
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Liquid Cohort (Group II) - Treatment A
    Arm description
    Sodium Alginate 20 ml single dose by mouth under fasted condition Total 12 subjects completed period 1 and 2 in group II (Liquid Cohort).
    Arm type
    Experimental

    Investigational medicinal product name
    Sodium Alginate Oral Suspension
    Investigational medicinal product code
    Other name
    Gaviscon Double Action Liquid
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Sodium Alginate 20 ml (sodium alginate 500 mg , sodium bicarbonate 213 mg, and calcium carbonate 325 mg per sachet) sachet by mouth.

    Number of subjects in period 2 [1]
    Liquid Cohort (Group II) - Treatment A
    Started
    12
    Completed
    12
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Six subjects were in Group I (Tablet cohort). This was a separate group to assess the suitability of the custom-designed pH catheter and pH monitoring methodology.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment 1
    Reporting group description
    All subjects (AS) population: All subjects recruited to the study.

    Reporting group values
    Treatment 1 Total
    Number of subjects
    20 20
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    20 20
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    25.4 ± 5.6 -
    Gender categorical
    Units: Subjects
        Female
    8 8
        Male
    12 12
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    20 20
    Race
    Units: Subjects
        Caucasian
    19 19
        Asian
    1 1
    Height
    Units: cm
        arithmetic mean (standard deviation)
    178.01 ± 9.36 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    69.87 ± 9.79 -
    BMI
    BMI - Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    21.9 ± 1.4 -

    End points

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    End points reporting groups
    Reporting group title
    Liquid Cohort (Group II): Treatment P
    Reporting group description
    Placebo Liquid 2 x 10 ml sachets single dose by mouth under fasted condition. Total 14 subjects received Placebo in Period 1 (8 subjects) and Period 2 (6 subjects) with 5 to 14 days washout period between dosing. Two subjects withdrew from the study during washout period.

    Reporting group title
    Tablet Cohort (Group I): Treatment B
    Reporting group description
    2 x Chewable tablets (calcium carbonate 680 mg and magnesium carbonate 80 mg per tablet) single dose by mouth under fasted condition. This was a separate group to assess the suitability of the custom-designed pH catheter and pH monitoring methodology.
    Reporting group title
    Liquid Cohort (Group II) - Treatment A
    Reporting group description
    Sodium Alginate 20 ml single dose by mouth under fasted condition Total 12 subjects completed period 1 and 2 in group II (Liquid Cohort).

    Primary: Mean Percentage of Time that pH ≥4 Over 0-30 Minutes Post-Dose Across Electrodes 5 to 10 in Liquid Cohort (Group II)

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    End point title
    Mean Percentage of Time that pH ≥4 Over 0-30 Minutes Post-Dose Across Electrodes 5 to 10 in Liquid Cohort (Group II) [1]
    End point description
    Intention-to-treat (ITT) population: All subjects who were recruited to the study and had some pH data for at least one treatment visit.
    End point type
    Primary
    End point timeframe
    From 0 to 30 minutes post-dose in visit 2 (Period 1) and visit 3 (Period 2)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Tablet cohort (Group I) was used only to assess the methodology and was not included in the analysis of the primary endpoint.
    End point values
    Liquid Cohort (Group II): Treatment P Liquid Cohort (Group II) - Treatment A
    Number of subjects analysed
    14
    12
    Units: Percentage of time (%)
        arithmetic mean (standard deviation)
    4.7 ± 8.7
    46.8 ± 29.2
    Statistical analysis title
    Treatment A versus P at pH ≥4 over >0 - ≤30 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0004
    Method
    ANCOVA
    Confidence interval

    Secondary: Mean Percentage of Time that pH ≥4 Over 30-60 Minutes Post-Dose Across Electrodes 5 to 10

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    End point title
    Mean Percentage of Time that pH ≥4 Over 30-60 Minutes Post-Dose Across Electrodes 5 to 10
    End point description
    ITT population. This endpoint was compared between sodium alginate oral suspension and placebo. For calcium carbonate / magnesium carbonate chewable tablets, this endpoint was assessed non-comparatively.
    End point type
    Secondary
    End point timeframe
    From 30 to 60 minutes post-dose in visit 2 (Period 1) and visit 3 (Period 2)
    End point values
    Liquid Cohort (Group II): Treatment P Tablet Cohort (Group I): Treatment B Liquid Cohort (Group II) - Treatment A
    Number of subjects analysed
    14
    6
    12
    Units: Percentage of time (%)
        arithmetic mean (standard deviation)
    3.9 ± 9.8
    12.1 ± 16.2
    15.7 ± 31.8
    Statistical analysis title
    Treatment A versus P at pH ≥4 over >30 - ≤60 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1379
    Method
    ANCOVA
    Confidence interval

    Secondary: Mean Percentage of Time that pH ≥3 Over 0-30 and 30-60 Minutes Post-Dose Across Electrodes 5 to 10

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    End point title
    Mean Percentage of Time that pH ≥3 Over 0-30 and 30-60 Minutes Post-Dose Across Electrodes 5 to 10
    End point description
    ITT population. This endpoint was compared between sodium alginate oral suspension and placebo. For calcium carbonate / magnesium carbonate chewable tablets, this endpoint was assessed non-comparatively.
    End point type
    Secondary
    End point timeframe
    Up to 60 minutes post-dose in visit 2 (Period 1) and visit 3 (Period 2)
    End point values
    Liquid Cohort (Group II): Treatment P Tablet Cohort (Group I): Treatment B Liquid Cohort (Group II) - Treatment A
    Number of subjects analysed
    14
    6
    12
    Units: Percentage of time (%)
    arithmetic mean (standard deviation)
        Interval >0 - ≤30 min
    6.6 ± 9.2
    57.2 ± 20.5
    49 ± 30.2
        Interval >30 - ≤60 min
    6.6 ± 17.4
    16.5 ± 18
    16.8 ± 33.2
    Statistical analysis title
    Treatment A versus P at pH ≥3 over > 0 - ≤ 30 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0024
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Treatment A versus P at pH ≥3 over >30 - ≤60 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3601
    Method
    ANCOVA
    Confidence interval

    Secondary: Mean Percentage of Time that pH ≥3 and pH ≥4 over 10 Minute Intervals post-dose across electrodes 5 to 10

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    End point title
    Mean Percentage of Time that pH ≥3 and pH ≥4 over 10 Minute Intervals post-dose across electrodes 5 to 10
    End point description
    ITT population. This endpoint was compared between sodium alginate oral suspension and placebo. For calcium carbonate / magnesium carbonate chewable tablets, this endpoint was assessed non-comparatively.
    End point type
    Secondary
    End point timeframe
    Up to 60 minutes post-dose in visit 2 (Period 1) and visit 3 (Period 2)
    End point values
    Liquid Cohort (Group II): Treatment P Tablet Cohort (Group I): Treatment B Liquid Cohort (Group II) - Treatment A
    Number of subjects analysed
    14
    6
    12
    Units: Percentage of time (%)
    arithmetic mean (standard deviation)
        pH ≥3 over >0 - ≤10 min
    11.4 ± 13.4
    60 ± 17
    69.7 ± 20.5
        pH ≥3 over >10 - ≤20 min
    4.5 ± 8.7
    67.7 ± 31.5
    49.8 ± 40.6
        pH ≥3 over >20 - ≤30 min
    3.9 ± 9.1
    43.4 ± 29.3
    26.9 ± 43.2
        pH ≥3 over >30 - ≤40 min
    6.2 ± 16.4
    14.1 ± 12.2
    20.2 ± 36.5
        pH ≥3 over >40 - ≤50 min
    6.4 ± 16.8
    14.3 ± 16.7
    15.8 ± 33.7
        pH ≥3 over >50 - ≤60 min
    7.2 ± 19
    21.1 ± 39.1
    14.2 ± 30.5
        pH ≥4 over >0 - ≤10 min
    8.6 ± 11.2
    54.9 ± 16.9
    66.1 ± 20
        pH ≥4 over >10 - ≤20 min
    3.3 ± 8.5
    60.7 ± 30.5
    48 ± 40.8
        pH ≥4 over >20 - ≤30 min
    2.3 ± 8.3
    32.5 ± 22.9
    25.8 ± 41.9
        pH ≥4 over >30 - ≤40 min
    3.3 ± 8.8
    8.3 ± 7.8
    18.2 ± 34.3
        pH ≥4 over >40 - ≤50 min
    2.7 ± 7.8
    8.9 ± 11.1
    15.2 ± 32.5
        pH ≥4 over >50 - ≤60 min
    5.6 ± 14.3
    18.9 ± 39.3
    13.4 ± 29.1
    Statistical analysis title
    Treatment A versus P at pH ≥3 over >0 - ≤10 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Treatment A versus P at pH ≥3 over >10 - ≤20 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.004
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Treatment A versus P at pH ≥3 over >20 - ≤30 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1314
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Treatment A versus P at pH ≥3 over >30 - ≤40 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1972
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Treatment A versus P at pH ≥3 over >40 - ≤50 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3306
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Treatment A versus P at pH ≥3 over >50 - ≤60 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3875
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Treatment A versus P at pH ≥4 over >0 - ≤10 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Treatment A versus P at pH ≥4 over >10 - ≤20 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0033
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Treatment A versus P at pH ≥4 over >20 - ≤30 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1317
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Treatment A versus P at pH ≥4 over >30 - ≤40 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2167
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Treatment A versus P at pH ≥4 over >40 - ≤50 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2819
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Treatment A versus P at pH ≥4 over >50 - ≤60 min
    Comparison groups
    Liquid Cohort (Group II): Treatment P v Liquid Cohort (Group II) - Treatment A
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3953
    Method
    ANCOVA
    Confidence interval

    Secondary: Mean Percentage of Time that pH ≥3 and pH ≥4 Over the 10 minute intervals at each electrode

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    End point title
    Mean Percentage of Time that pH ≥3 and pH ≥4 Over the 10 minute intervals at each electrode
    End point description
    ITT population. This endpoint was compared between sodium alginate oral suspension and placebo. For calcium carbonate/magnesium carbonate chewable tablets, this endpoint was assessed non-comparatively.
    End point type
    Secondary
    End point timeframe
    Up to 60 minutes post-dose in visit 2 (Period 1) and visit 3 (Period 2)
    End point values
    Liquid Cohort (Group II): Treatment P Tablet Cohort (Group I): Treatment B Liquid Cohort (Group II) - Treatment A
    Number of subjects analysed
    14
    6
    12
    Units: Percentage of time (%)
    arithmetic mean (standard deviation)
        Electrode 1 pH ≥3 over >0 - ≤10 min
    99 ± 1.1
    99.5 ± 0
    99.4 ± 0.4
        Electrode 2 pH ≥3 over >0 - ≤10 min
    95.4 ± 8.1
    99.5 ± 0
    98.8 ± 0.9
        Electrode 3 pH ≥3 over >0 - ≤10 min
    49 ± 42.4
    94 ± 4.9
    89.3 ± 9.4
        Electrode 4 pH ≥3 over >0 - ≤10 min
    27.2 ± 34.7
    88.2 ± 5.3
    76.4 ± 19.9
        Electrode 5 pH ≥3 over >0 - ≤10 min
    35.4 ± 40
    82.8 ± 6
    77.5 ± 16.7
        Electrode 6 pH ≥3 over >0 - ≤10 min
    22.9 ± 32.9
    79.3 ± 9.7
    81.6 ± 14.5
        Electrode 7 pH ≥3 over >0 - ≤10 min
    3.3 ± 7
    70.9 ± 17
    74.7 ± 18.5
        Electrode 8 pH ≥3 over >0 - ≤10 min
    4.4 ± 9.1
    40 ± 27.3
    59 ± 32.3
        Electrode 9 pH ≥3 over >0 - ≤10 min
    1.4 ± 2.4
    37.1 ± 26
    61.8 ± 33
        Electrode 10 pH ≥3 over >0 - ≤10 min
    1 ± 1.9
    49.7 ± 36.9
    63.4 ± 26.5
        Electrode 1 pH ≥3 over >10 - ≤20 min
    99.4 ± 0.4
    99.5 ± 0
    99.5 ± 0
        Electrode 2 pH ≥3 over >10 - ≤20 min
    94.2 ± 18.7
    98.5 ± 1.1
    99.4 ± 0.2
        Electrode 3 pH ≥3 over >10 - ≤20 min
    48.7 ± 41.4
    66 ± 35.1
    59.6 ± 40.2
        Electrode 4 pH ≥3 over >10 - ≤20 min
    14.9 ± 33
    65.8 ± 28.8
    37.5 ± 38.8
        Electrode 5 pH ≥3 over >10 - ≤20 min
    13.5 ± 27.7
    70.4 ± 35.1
    38.3 ± 40.7
        Electrode 6 pH ≥3 over >10 - ≤20 min
    9.7 ± 24.2
    78.8 ± 33.2
    47.7 ± 44.7
        Electrode 7 pH ≥3 over >10 - ≤20 min
    0.6 ± 2
    81.7 ± 36.5
    49.7 ± 43
        Electrode 8 pH ≥3 over >10 - ≤20 min
    2 ± 5.4
    48.9 ± 46.3
    50.6 ± 42.6
        Electrode 9 pH ≥3 over >10 - ≤20 min
    1 ± 2.8
    63.3 ± 44.4
    55.2 ± 42.7
        Electrode 10 pH ≥3 over >10 - ≤20 min
    0.6 ± 2.1
    63.1 ± 39.6
    57.6 ± 39
        Electrode 1 pH ≥3 over >20 - ≤30 min
    99.1 ± 0.6
    99.5 ± 0
    99.3 ± 0.4
        Electrode 2 pH ≥3 over >20 - ≤30 min
    92.4 ± 19.7
    98.8 ± 0.6
    98.2 ± 2
        Electrode 3 pH ≥3 over >20 - ≤30 min
    37.8 ± 38.2
    50.1 ± 35.9
    50.3 ± 45.9
        Electrode 4 pH ≥3 over >20 - ≤30 min
    10.1 ± 26.1
    20.8 ± 23.9
    25.5 ± 38.2
        Electrode 5 pH ≥3 over >20 - ≤30 min
    7.3 ± 25.6
    42.5 ± 33.9
    23.8 ± 41.8
        Electrode 6 pH ≥3 over >20 - ≤30 min
    10.3 ± 25.8
    52 ± 33.6
    32.9 ± 48.4
        Electrode 7 pH ≥3 over >20 - ≤30 min
    0.7 ± 2.3
    41.7 ± 33.4
    24.9 ± 45
        Electrode 8 pH ≥3 over >20 - ≤30 min
    4.9 ± 18.2
    32.3 ± 37.7
    24.9 ± 45
        Electrode 9 pH ≥3 over >20 - ≤30 min
    0.3 ± 0.9
    42.6 ± 40.3
    26.8 ± 44.3
        Electrode 10 pH ≥3 over >20 - ≤30 min
    0.1 ± 0.4
    49.3 ± 39.3
    28.2 ± 43.6
        Electrode 1 pH ≥3 over >30 - ≤40 min
    98.9 ± 1.2
    99.4 ± 0.3
    99.3 ± 0.6
        Electrode 2 pH ≥3 over >30 - ≤40 min
    94.2 ± 13.6
    98.5 ± 0.8
    97.1 ± 5.7
        Electrode 3 pH ≥3 over >30 - ≤40 min
    46.5 ± 42.8
    46.6 ± 40
    49 ± 45.8
        Electrode 4 pH ≥3 over >30 - ≤40 min
    9.5 ± 26.2
    3.1 ± 3.8
    23.6 ± 37
        Electrode 5 pH ≥3 over >30 - ≤40 min
    7.2 ± 26.4
    5 ± 5.7
    15.3 ± 35.1
        Electrode 6 pH ≥3 over >30 - ≤40 min
    12.3 ± 31.3
    6.9 ± 7.7
    25.3 ± 43.3
        Electrode 7 pH ≥3 over >30 - ≤40 min
    0.1 ± 0.5
    11.5 ± 18.6
    17.4 ± 35.6
        Electrode 8 pH ≥3 over >30 - ≤40 min
    7.2 ± 26.6
    14.3 ± 16.8
    20.6 ± 38.8
        Electrode 9 pH ≥3 over >30 - ≤40 min
    6.3 ± 23.3
    21.6 ± 26.6
    22.3 ± 40.9
        Electrode 10 pH ≥3 over >30 - ≤40 min
    4.2 ± 15.1
    25.4 ± 30.2
    20.4 ± 38.6
        Electrode 1 pH ≥3 over >40 - ≤50 min
    99.3 ± 0.6
    98.4 ± 1.9
    98.9 ± 0.9
        Electrode 2 pH ≥3 over >40 - ≤50 min
    97.5 ± 3.4
    96.6 ± 5.9
    93.5 ± 15.4
        Electrode 3 pH ≥3 over >40 - ≤50 min
    44.5 ± 40
    34 ± 30.2
    48.5 ± 45.5
        Electrode 4 pH ≥3 over >40 - ≤50 min
    9.8 ± 26.1
    1.4 ± 1.8
    20.6 ± 36.3
        Electrode 5 pH ≥3 over >40 - ≤50 min
    7 ± 24.6
    6.3 ± 9.3
    17 ± 38.6
        Electrode 6 pH ≥3 over >40 - ≤50 min
    12.9 ± 33.1
    13.6 ± 21.4
    24.9 ± 45
        Electrode 7 pH ≥3 over >40 - ≤50 min
    0.5 ± 1.6
    12.7 ± 19.8
    9.6 ± 28.7
        Electrode 8 pH ≥3 over >40 - ≤50 min
    7.3 ± 26.6
    16.5 ± 25.6
    11.1 ± 29.5
        Electrode 9 pH ≥3 over >40 - ≤50 min
    7.1 ± 26.6
    19 ± 19.2
    16.3 ± 38.1
        Electrode 10 pH ≥3 over >40 - ≤50 min
    3.4 ± 12.7
    17.6 ± 22.5
    15.9 ± 37.2
        Electrode 1 pH ≥3 over >50 - ≤60 min
    98.9 ± 1.2
    99.4 ± 0.3
    99.3 ± 0.5
        Electrode 2 pH ≥3 over >50 - ≤60 min
    97 ± 4.8
    98.6 ± 1.2
    98.2 ± 1.5
        Electrode 3 pH ≥3 over >50 - ≤60 min
    53.8 ± 42.5
    30.3 ± 30.8
    43.9 ± 40.3
        Electrode 4 pH ≥3 over >50 - ≤60 min
    13.3 ± 31.2
    23.1 ± 39.7
    17.9 ± 35.7
        Electrode 5 pH ≥3 over >50 - ≤60 min
    7.3 ± 26.5
    19.9 ± 39.6
    17.3 ± 38.5
        Electrode 6 pH ≥3 over >50 - ≤60 min
    14.1 ± 33.2
    19.7 ± 39.6
    25.4 ± 44.7
        Electrode 7 pH ≥3 over >50 - ≤60 min
    0.2 ± 0.9
    25.3 ± 41.9
    8.3 ± 28.7
        Electrode 8 pH ≥3 over >50 - ≤60 min
    7.3 ± 26.6
    23.3 ± 40.7
    8.4 ± 28.7
        Electrode 9 pH ≥3 over >50 - ≤60 min
    7.1 ± 26.6
    17.6 ± 40.1
    16 ± 37.5
        Electrode 10 pH ≥3 over >50 - ≤60 min
    7.3 ± 26.6
    20.8 ± 39.2
    9.8 ± 26
        Electrode 1 pH ≥4 over >0 - ≤10 min
    98.7 ± 2
    99.5 ± 0
    99.4 ± 0.4
        Electrode 2 pH ≥4 over >0 - ≤10 min
    94.4 ± 11
    99.5 ± 0
    98.7 ± 0.9
        Electrode 3 pH ≥4 over >0 - ≤10 min
    46.4 ± 43.2
    89.1 ± 11.1
    87.5 ± 10.9
        Electrode 4 pH ≥4 over >0 - ≤10 min
    24.6 ± 33.6
    86.3 ± 6.8
    73.5 ± 21.8
        Electrode 5 pH ≥4 over >0 - ≤10 min
    28.6 ± 36.7
    79.9 ± 7.9
    75.8 ± 18.7
        Electrode 6 pH ≥4 over >0 - ≤10 min
    18 ± 28.6
    75.7 ± 9.2
    80.6 ± 15.6
        Electrode 7 pH ≥4 over >0 - ≤10 min
    1.5 ± 2.9
    68.1 ± 16.4
    73.6 ± 19.3
        Electrode 8 pH ≥4 over >0 - ≤10 min
    1.7 ± 4.8
    32.1 ± 30.4
    57.7 ± 32.7
        Electrode 9 pH ≥4 over >0 - ≤10 min
    0.9 ± 1.8
    28.7 ± 27
    53.8 ± 31.7
        Electrode 10 pH ≥4 over >0 - ≤10 min
    0.7 ± 1.7
    45.1 ± 34.7
    55.2 ± 30.7
        Electrode 1 pH ≥4 over >10 - ≤20 min
    99.4 ± 0.4
    99.5 ± 0
    99.5 ± 0
        Electrode 2 pH ≥4 over >10 - ≤20 min
    93.1 ± 22.4
    98.3 ± 1.4
    99.4 ± 0.2
        Electrode 3 pH ≥4 over >10 - ≤20 min
    42.6 ± 39
    59.1 ± 38.7
    56.2 ± 41.1
        Electrode 4 pH ≥4 over >10 - ≤20 min
    14 ± 32.9
    55.3 ± 27
    35.4 ± 38.3
        Electrode 5 pH ≥4 over >10 - ≤20 min
    10.7 ± 26.2
    65.4 ± 35.7
    36.8 ± 41.6
        Electrode 6 pH ≥4 over >10 - ≤20 min
    7.7 ± 23.8
    70.9 ± 32
    46.2 ± 44.7
        Electrode 7 pH ≥4 over >10 - ≤20 min
    0.5 ± 1.8
    75.3 ± 36.3
    48.4 ± 43
        Electrode 8 pH ≥4 over >10 - ≤20 min
    0 ± 0.2
    43 ± 47.6
    48.7 ± 42.2
        Electrode 9 pH ≥4 over >10 - ≤20 min
    0.4 ± 1.6
    56.4 ± 43.5
    53.4 ± 42.4
        Electrode 10 pH ≥4 over >10 - ≤20 min
    0.2 ± 0.9
    53.1 ± 40.7
    54.5 ± 40
        Electrode 1 pH ≥4 over >20 - ≤30 min
    99 ± 0.7
    99.5 ± 0
    99.2 ± 0.8
        Electrode 2 pH ≥4 over >20 - ≤30 min
    91.1 ± 22.8
    98.8 ± 0.6
    95.9 ± 9.6
        Electrode 3 pH ≥4 over >20 - ≤30 min
    32 ± 36.1
    42.6 ± 36.8
    48.5 ± 45.9
        Electrode 4 pH ≥4 over >20 - ≤30 min
    9.4 ± 26.1
    12.9 ± 14.7
    23.8 ± 37.7
        Electrode 5 pH ≥4 over >20 - ≤30 min
    6.9 ± 25.5
    34.4 ± 33.4
    21.7 ± 39.1
        Electrode 6 pH ≥4 over >20 - ≤30 min
    6.4 ± 22.1
    37.2 ± 30.5
    32.3 ± 47.5
        Electrode 7 pH ≥4 over >20 - ≤30 min
    0.6 ± 2.1
    31.8 ± 33.2
    24.9 ± 45
        Electrode 8 pH ≥4 over >20 - ≤30 min
    0 ± 0
    25.1 ± 37.1
    24.9 ± 45
        Electrode 9 pH ≥4 over >20 - ≤30 min
    0 ± 0
    31.6 ± 28.8
    26.2 ± 44.4
        Electrode 10 pH ≥4 over >20 - ≤30 min
    0 ± 0.2
    35.1 ± 34.5
    25 ± 40
        Electrode 1 pH ≥4 over >30 - ≤40 min
    98.8 ± 1.3
    99.4 ± 0.3
    99.3 ± 0.6
        Electrode 2 pH ≥4 over >30 - ≤40 min
    92 ± 19.3
    98.5 ± 0.8
    96.9 ± 5.9
        Electrode 3 pH ≥4 over >30 - ≤40 min
    42.1 ± 40.4
    39.1 ± 36.5
    46.8 ± 46
        Electrode 4 pH ≥4 over >30 - ≤40 min
    8.3 ± 26.3
    2.2 ± 2.9
    21.2 ± 36.3
        Electrode 5 pH ≥4 over >30 - ≤40 min
    7.1 ± 26.4
    3.8 ± 5.3
    13.8 ± 32.6
        Electrode 6 pH ≥4 over >30 - ≤40 min
    5.7 ± 20.7
    4.9 ± 7.2
    24.1 ± 42.7
        Electrode 7 pH ≥4 over >30 - ≤40 min
    0 ± 0.2
    6 ± 9.6
    16 ± 34.6
        Electrode 8 pH ≥4 over >30 - ≤40 min
    6 ± 22.3
    7.6 ± 8.9
    19 ± 37.1
        Electrode 9 pH ≥4 over >30 - ≤40 min
    1.1 ± 4.1
    10.6 ± 15.4
    19.3 ± 38
        Electrode 10 pH ≥4 over >30 - ≤40 min
    0.1 ± 0.4
    17 ± 22.8
    16.9 ± 33.3
        Electrode 1 pH ≥4 over >40 - ≤50 min
    99.3 ± 0.6
    98.2 ± 2.4
    98.9 ± 0.9
        Electrode 2 pH ≥4 over >40 - ≤50 min
    96.6 ± 5.7
    96.4 ± 6.4
    93 ± 16.1
        Electrode 3 pH ≥4 over >40 - ≤50 min
    40.2 ± 39.8
    23 ± 21.3
    46.6 ± 44.9
        Electrode 4 pH ≥4 over >40 - ≤50 min
    8.9 ± 25.6
    0.9 ± 1.4
    19.3 ± 35.9
        Electrode 5 pH ≥4 over >40 - ≤50 min
    6.4 ± 23.7
    3.3 ± 5.1
    16.9 ± 38.6
        Electrode 6 pH ≥4 over >40 - ≤50 min
    5.4 ± 19.8
    5.4 ± 7.7
    24.9 ± 45
        Electrode 7 pH ≥4 over >40 - ≤50 min
    0.4 ± 1.6
    5.8 ± 9.1
    9.5 ± 28.6
        Electrode 8 pH ≥4 over >40 - ≤50 min
    2.4 ± 8.8
    11.1 ± 17.6
    9.5 ± 28.6
        Electrode 9 pH ≥4 over >40 - ≤50 min
    1.3 ± 4.9
    13.1 ± 16
    16 ± 37.3
        Electrode 10 pH ≥4 over >40 - ≤50 min
    0 ± 0
    14.8 ± 21.6
    14.4 ± 33.7
        Electrode 1 pH ≥4 over >50 - ≤60 min
    98.9 ± 1.2
    99.4 ± 0.3
    99.3 ± 0.5
        Electrode 2 pH ≥4 over >50 - ≤60 min
    96.5 ± 6.2
    98.4 ± 1.5
    97.9 ± 1.6
        Electrode 3 pH ≥4 over >50 - ≤60 min
    49.2 ± 40.3
    14.9 ± 13.2
    38.5 ± 37.4
        Electrode 4 pH ≥4 over >50 - ≤60 min
    12.3 ± 29.9
    19.2 ± 35.4
    16.5 ± 35.7
        Electrode 5 pH ≥4 over >50 - ≤60 min
    7.2 ± 26.6
    17.4 ± 38.4
    16.8 ± 38.6
        Electrode 6 pH ≥4 over >50 - ≤60 min
    9.5 ± 24.6
    18.8 ± 39.9
    25.3 ± 44.5
        Electrode 7 pH ≥4 over >50 - ≤60 min
    0.2 ± 0.7
    21.7 ± 40
    8.3 ± 28.7
        Electrode 8 pH ≥4 over >50 - ≤60 min
    7.2 ± 26.4
    20.1 ± 39.8
    8.3 ± 28.7
        Electrode 9 pH ≥4 over >50 - ≤60 min
    7.1 ± 26.6
    16.9 ± 40.5
    15.7 ± 36.7
        Electrode 10 pH ≥4 over >50 - ≤60 min
    2.3 ± 8.4
    18.6 ± 39.8
    6.3 ± 17.8
    No statistical analyses for this end point

    Secondary: Mean Percentage of Time that pH ≥3 and pH ≥4 Over the 30 minute intervals at each electrode

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    End point title
    Mean Percentage of Time that pH ≥3 and pH ≥4 Over the 30 minute intervals at each electrode
    End point description
    ITT population. These endpoints were compared between sodium alginate oral suspension and placebo. For calcium carbonate/magnesium carbonate chewable tablets, these endpoints were assessed non-comparatively.
    End point type
    Secondary
    End point timeframe
    Up to 60 minutes post-dose in visit 2 (Period 1) and visit 3 (Period 2)
    End point values
    Liquid Cohort (Group II): Treatment P Tablet Cohort (Group I): Treatment B Liquid Cohort (Group II) - Treatment A
    Number of subjects analysed
    14
    6
    12
    Units: Percentage of time (%)
    arithmetic mean (standard deviation)
        Electrode 1 pH ≥3 over >0 - ≤30 min
    99.5 ± 0.6
    99.8 ± 0
    99.7 ± 0.2
        Electrode 2 pH ≥3 over >0 - ≤30 min
    94.3 ± 15.5
    99.3 ± 0.3
    99.2 ± 0.8
        Electrode 3 pH ≥3 over >0 - ≤30 min
    45.3 ± 38.5
    70.2 ± 23.3
    66.6 ± 31.1
        Electrode 4 pH ≥3 over >0 - ≤30 min
    17.4 ± 28.3
    58.4 ± 17.9
    46.6 ± 26.8
        Electrode 5 pH ≥3 over >0 - ≤30 min
    18.8 ± 27.3
    65.5 ± 22.2
    46.7 ± 30.3
        Electrode 6 pH ≥3 over >0 - ≤30 min
    14.3 ± 25.5
    70.3 ± 19.5
    54.2 ± 32.8
        Electrode 7 pH ≥3 over >0 - ≤30 min
    1.5 ± 3
    65 ± 21.9
    49.9 ± 30.9
        Electrode 8 pH ≥3 over >0 - ≤30 min
    3.7 ± 9.1
    40.5 ± 34
    45 ± 33.6
        Electrode 9 pH ≥3 over >0 - ≤30 min
    0.9 ± 1.5
    47.9 ± 31.2
    48.2 ± 33.4
        Electrode 10 pH ≥3 over >0 - ≤30 min
    0.6 ± 1
    54.3 ± 29.7
    50 ± 27
        Electrode 1 pH ≥3 over >30 - ≤60 min
    99.4 ± 0.8
    99.4 ± 0.6
    99.5 ± 0.4
        Electrode 2 pH ≥3 over >30 - ≤60 min
    96.6 ± 6.5
    98.2 ± 1.7
    96.6 ± 7.1
        Electrode 3 pH ≥3 over >30 - ≤60 min
    48.5 ± 40.2
    37.1 ± 28.1
    47.3 ± 43.5
        Electrode 4 pH ≥3 over >30 - ≤60 min
    10.9 ± 27
    9.2 ± 12.9
    20.8 ± 35.9
        Electrode 5 pH ≥3 over >30 - ≤60 min
    7.2 ± 25.9
    10.5 ± 15.5
    16.5 ± 37.4
        Electrode 6 pH ≥3 over >30 - ≤60 min
    13.1 ± 32.6
    13.4 ± 19.8
    25.3 ± 44.4
        Electrode 7 pH ≥3 over >30 - ≤60 min
    0.3 ± 1
    16.5 ± 23.8
    11.8 ± 29.4
        Electrode 8 pH ≥3 over >30 - ≤60 min
    7.2 ± 26.7
    18.1 ± 22.8
    13.4 ± 30.1
        Electrode 9 pH ≥3 over >30 - ≤60 min
    6.9 ± 25.6
    19.4 ± 19.9
    18.3 ± 37.8
        Electrode 10 pH ≥3 over >30 - ≤60 min
    5 ± 18.2
    21.3 ± 24
    15.4 ± 32.7
        Electrode 1 pH ≥4 over >0 - ≤30 min
    99.4 ± 0.8
    99.8 ± 0
    99.7 ± 0.3
        Electrode 2 pH ≥4 over >0 - ≤30 min
    93.2 ± 18.7
    99.2 ± 0.4
    98.4 ± 3.2
        Electrode 3 pH ≥4 over >0 - ≤30 min
    40.5 ± 37.3
    63.8 ± 26.2
    64.2 ± 32
        Electrode 4 pH ≥4 over >0 - ≤30 min
    16.1 ± 28.3
    51.7 ± 15.1
    44.4 ± 27.2
        Electrode 5 pH ≥4 over >0 - ≤30 min
    15.4 ± 26.3
    60.1 ± 22.4
    44.9 ± 30.3
        Electrode 6 pH ≥4 over >0 - ≤30 min
    10.8 ± 23.2
    61.6 ± 18.2
    53.2 ± 33
        Electrode 7 pH ≥4 over >0 - ≤30 min
    0.9 ± 2
    58.6 ± 22.4
    49.1 ± 31.3
        Electrode 8 pH ≥4 over >0 - ≤30 min
    0.6 ± 1.7
    33.5 ± 35.2
    43.9 ± 33.8
        Electrode 9 pH ≥4 over >0 - ≤30 min
    0.4 ± 0.8
    39.1 ± 27.6
    44.7 ± 30.5
        Electrode 10 pH ≥4 over >0 - ≤30 min
    0.3 ± 0.6
    44.6 ± 30.7
    45.1 ± 24.5
        Electrode 1 pH ≥4 over >30 - ≤60 min
    99.3 ± 0.8
    99.3 ± 0.8
    99.5 ± 0.4
        Electrode 2 pH ≥4 over >30 - ≤60 min
    95.4 ± 9.2
    98.1 ± 1.8
    96.3 ± 7.5
        Electrode 3 pH ≥4 over >30 - ≤60 min
    44 ± 38.6
    25.7 ± 20.8
    44.1 ± 42.2
        Electrode 4 pH ≥4 over >30 - ≤60 min
    9.8 ± 26.7
    7.4 ± 11.3
    19.1 ± 35.6
        Electrode 5 pH ≥4 over >30 - ≤60 min
    6.9 ± 25.7
    8.2 ± 14
    15.9 ± 36.5
        Electrode 6 pH ≥4 over >30 - ≤60 min
    6.9 ± 21.1
    9.8 ± 15.4
    24.8 ± 44.2
        Electrode 7 pH ≥4 over >30 - ≤60 min
    0.2 ± 0.8
    11.2 ± 16.9
    11.3 ± 29.3
        Electrode 8 pH ≥4 over >30 - ≤60 min
    5.2 ± 19.2
    13 ± 18.6
    12.3 ± 29.4
        Electrode 9 pH ≥4 over >30 - ≤60 min
    3.2 ± 11.9
    13.6 ± 18.5
    17.1 ± 37.2
        Electrode 10 pH ≥4 over >30 - ≤60 min
    0.8 ± 2.8
    16.8 ± 21.9
    12.6 ± 27
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to follow-up (Day 7)
    Adverse event reporting additional description
    Treatment-emergent adverse events (TEAE) for Safety population
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Adverse Events
    Reporting group description
    -

    Serious adverse events
    Adverse Events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Adverse Events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 20 (25.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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