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    Clinical Trial Results:
    A randomised, single dose, crossover, open label, placebo controlled confirmatory study in healthy volunteers to characterise the acid neutralisation activity of Gaviscon Double Action Liquid in the fasted state, using an intragastric and oesophageal pH catheter.

    Summary
    EudraCT number
    		 2016-000539-42
    Trial protocol
    		 NL  
    Global end of trial date
    07 Sep 2016

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Feb 2019
    First version publication date
    20 Oct 2017
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Slight changes in disposition and title.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RB2-NL-1518
    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, 0044 1482 326 151, clinicalrequests@rb.com
    Scientific contact
    Clinical Research Director, Clinical Research, Reckitt Benckiser Healthcare (UK) Limited, 0044 1482 326 151, 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
    20 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this confirmatory study is to confirm the acid neutralisation action of Gaviscon Double Action Liquid versus placebo liquid within the stomach.
    Protection of trial subjects
    This study was conducted in accordance with the 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
    06 May 2016
    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 the Netherlands.

    Pre-assignment
    Screening details
    		 Healthy volunteers of both genders were recruited into this study. Total 20 subjects were randomized.

    Period 1
    Period 1 title
    Period 1: Placebo and Gaviscon
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open-label study; subjects, clinic staff and consultant gastroenterologist remained unblinded throughout the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo Liquid sachets 20 ml single dose by mouth under fasted condition. There was a 5 to 14 days washout period between each treatment administration.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    10 ml sachet, for oral use

    Arm title
    		 Gaviscon Double Action Liquid Sachets 20 ml
    Arm description
    		 Gaviscon Double Action Liquid Sachets 20 ml dose of single dose by mouth under fasted condition. There was a 5 to 14 days washout period between each treatment administration
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gaviscon Double Action Liquid Sachets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Gaviscon Double Action Liquid 20 ml sachets (each 10 ml sachet contained sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg) single dose by mouth.

    Number of subjects in period 1
    		Placebo Gaviscon Double Action Liquid Sachets 20 ml
    Started
    10
    10
    Completed
    8
    6
    Not completed
    2
    4
         Physician decision
    2
    3
         Withdrew consent
    -
    1
    Period 2
    Period 2 title
    Period 2: Gaviscon and Placebo
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open-label study; subjects, clinic staff and consultant gastroenterologist remained unblinded throughout the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Gaviscon Double Action Liquid Sachets 20 ml
    Arm description
    		 Gaviscon Double Action Liquid Sachets 20 ml dose of single dose by mouth under fasted condition.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gaviscon Double Action Liquid Sachets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Gaviscon Double Action Liquid 20 ml sachets (each 10 ml sachet contained sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg) single dose by mouth.

    Arm title
    		 Placebo
    Arm description
    		 Placebo Liquid sachets 20 ml single dose by mouth under fasted condition.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo 10 ml sachet single dose by mouth.

    Number of subjects in period 2
    		Gaviscon Double Action Liquid Sachets 20 ml Placebo
    Started
    8
    6
    Completed
    6
    6
    Not completed
    2
    0
         Physician decision
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1: Placebo and Gaviscon
    Reporting group description
    		 -

    Reporting group values
    		 Period 1: Placebo and Gaviscon Total
    Number of subjects
    		 20 20
    Age categorical
    All subjects population
    Units: Subjects
        Adults (18-64 years)
    		 20 20
    Age continuous
    All subjects population
    Units: years
        arithmetic mean (standard deviation)
    		 23 ( 3 ) -
    Gender categorical
    All subjects population
    Units: Subjects
        Female
    		 11 11
        Male
    		 9 9
    Race
    All subjects population
    Units: Subjects
        White
    		 19 19
        Black Or African American
    		 1 1
    Smoking history
    All subjects population
    Units: Subjects
        Never Smoked
    		 17 17
        Currently Smoking
    		 3 3
    Drinking habits
    All subjects population
    Units: Subjects
        Yes
    		 18 18
        No
    		 2 2
    Drug use
    All subjects population
    Units: Subjects
        No
    		 20 20
    Height
    All subjects population
    Units: cm
        arithmetic mean (standard deviation)
    		 175.75 ( 9.14 ) -
    Weight
    All subjects population
    Units: kg
        arithmetic mean (standard deviation)
    		 68.41 ( 8.41 ) -
    BMI
    All subjects population
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 22.1 ( 1.54 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo Liquid sachets 20 ml single dose by mouth under fasted condition. There was a 5 to 14 days washout period between each treatment administration.

    Reporting group title
    Gaviscon Double Action Liquid Sachets 20 ml
    Reporting group description
    		 Gaviscon Double Action Liquid Sachets 20 ml dose of single dose by mouth under fasted condition. There was a 5 to 14 days washout period between each treatment administration
    Reporting group title
    Gaviscon Double Action Liquid Sachets 20 ml
    Reporting group description
    		 Gaviscon Double Action Liquid Sachets 20 ml dose of single dose by mouth under fasted condition.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo Liquid sachets 20 ml single dose by mouth under fasted condition.

    Subject analysis set title
    Period 1 and 2: Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT (Intention-to-treat) population: All subjects who were recruited to the study and had some post-treatment pH data for at least one treatment visit.

    Subject analysis set title
    Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT (Intention-to-treat) population: All subjects who were recruited to the study and had some post-treatment pH data for at least one treatment visit.

    Primary: Percentage of time that pH ≥4 over 0-30 minutes post-dose across electrodes 5 to 10

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    End point title
    		 Percentage of time that pH ≥4 over 0-30 minutes post-dose across electrodes 5 to 10
    End point description
    ITT population
    End point type
    Primary
    End point timeframe
    From 0 to 30 minutes post-dose on Day 1 of Period 1 and 2
    End point values
    		 Period 1 and 2: Placebo Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects analysed
    14
    13
    Units: Percentage of time (%)
        arithmetic mean (standard deviation)
    3.5 ( 2.7 )
    50.8 ( 28.6 )
    Statistical analysis title
    		 pH ≥4 over 0-30 minutes
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0051
    Method
    		 Wilcoxon Rank Sum Test
    Confidence interval

    Secondary: Percentage of time that pH ≥4 over the interval 30-60 minutes post-dose across electrodes 5 to 10

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    End point title
    		 Percentage of time that pH ≥4 over the interval 30-60 minutes post-dose across electrodes 5 to 10
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    From 30 to 60 minutes post-dose on Day 1 of Period 1 and 2
    End point values
    		 Period 1 and 2: Placebo Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects analysed
    14
    13
    Units: Percentage of time (%)
        arithmetic mean (standard deviation)
    6.6 ( 21.1 )
    8.7 ( 15.1 )
    Statistical analysis title
    		 pH ≥4 over the interval 30-60 minutes
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1705
    Method
    		 Wilcoxon Rank Sum Test
    Confidence interval

    Secondary: Percentage of time that pH ≥3 over the intervals 0-30 minutes and 30-60 minutes post-dose across electrodes 5 to 10

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    End point title
    		 Percentage of time that pH ≥3 over the intervals 0-30 minutes and 30-60 minutes post-dose across electrodes 5 to 10
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    From 0 to 60 minutes post-dose on Day 1 of Period 1 and 2
    End point values
    		 Period 1 and 2: Placebo Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects analysed
    14
    13
    Units: Percentage of time (%)
    arithmetic mean (standard deviation)
        over 0 - 30 minutes
    9 ( 9.2 )
    53.1 ( 28.7 )
        over 30 - 60 minutes
    10.5 ( 22.7 )
    10.8 ( 16 )
    Statistical analysis title
    		 pH ≥3 over the intervals 0-30 minutes
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 pH ≥3 over the intervals 30-60 minutes
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5752
    Method
    		 Wilcoxon Rank Sum Test
    Confidence interval

    Secondary: Percentage of time that pH ≥3 over 10 minute intervals post-dose across electrodes 5 to 10

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    End point title
    		 Percentage of time that pH ≥3 over 10 minute intervals post-dose across electrodes 5 to 10
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    From 0 to 60 minutes post-dose on Day 1 of Period 1 and 2
    End point values
    		 Period 1 and 2: Placebo Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects analysed
    14
    13
    Units: Percentage of time (%)
    arithmetic mean (standard deviation)
        pH ≥3 over 0 - 10 minutes
    16.3 ( 19.2 )
    59 ( 20.3 )
        pH ≥3 over 10 - 20 minutes
    5.7 ( 6.7 )
    63 ( 32 )
        pH ≥3 over 20 - 30 minutes
    5.1 ( 7.4 )
    36.7 ( 43.2 )
        pH ≥3 over 30 - 40 minutes
    9.4 ( 24.9 )
    24.3 ( 33.2 )
        pH ≥3 over 40 - 50 minutes
    10.7 ( 27.2 )
    5.6 ( 11.5 )
        pH ≥3 over 50 - 60 minutes
    11.1 ( 20 )
    2.4 ( 6.4 )
    Statistical analysis title
    		 0-10 minutes post-dose on Day 1 of Period 1 and 2
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 10-20 minutes post-dose on Day 1 of Period 1 and 2
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0051
    Method
    		 Wilcoxon Rank Sum Test
    Confidence interval
    Statistical analysis title
    		 20-30 minutes post-dose on Day 1 of Period 1 and 2
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0079
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 30-40 minutes post-dose on Day 1 of Period 1 and 2
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0651
    Method
    		 Wilcoxon Rank Sum Test
    Confidence interval
    Statistical analysis title
    		 40-50 minutes post-dose on Day 1 of Period 1 and 2
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9362
    Method
    		 Wilcoxon Rank Sum Test
    Confidence interval
    Statistical analysis title
    		 50-60 minutes post-dose on Day 1 of Period 1 and 2
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.376
    Method
    		 Wilcoxon Rank Sum Test
    Confidence interval

    Secondary: Percentage of time that pH ≥4 over 10 minute intervals post-dose across electrodes 5 to 10

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    End point title
    		 Percentage of time that pH ≥4 over 10 minute intervals post-dose across electrodes 5 to 10
    End point description
    End point type
    Secondary
    End point timeframe
    From 0 to 60 minutes post-dose on Day 1 of Period 1 and 2
    End point values
    		 Period 1 and 2: Placebo Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects analysed
    14
    13
    Units: Percentage of time (%)
    arithmetic mean (standard deviation)
        pH ≥4 over 0 - 10 minutes
    8.3 ( 7.6 )
    56.8 ( 19.7 )
        pH ≥4 over 10 - 20 minutes
    1.4 ( 2.1 )
    59.9 ( 33 )
        pH ≥4 over 20 - 30 minutes
    0.9 ( 2.1 )
    35 ( 42.4 )
        pH ≥4 over 30 - 40 minutes
    6.8 ( 23.7 )
    20 ( 30.9 )
        pH ≥4 over 40 - 50 minutes
    8 ( 26.4 )
    4.2 ( 10.3 )
        pH ≥4 over 50 - 60 minutes
    5 ( 13 )
    1.8 ( 6.1 )
    Statistical analysis title
    		 0-10 minutes post-dose on Day 1 of Period 1 and 2
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 10-20 minutes post-dose on Day 1 of Period 1 and 2
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0051
    Method
    		 Wilcoxon Rank Sum Test
    Confidence interval
    Statistical analysis title
    		 20-30 minutes post-dose on Day 1 of Period 1 and 2
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0047
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 30-40 minutes post-dose on Day 1 of Period 1 and 2
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0115
    Method
    		 Wilcoxon Rank Sum Test
    Confidence interval
    Statistical analysis title
    		 40-50 minutes post-dose on Day 1 of Period 1 and 2
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.935
    Method
    		 Wilcoxon Rank Sum Test
    Confidence interval
    Statistical analysis title
    		 50-60 minutes post-dose on Day 1 of Period 1 and 2
    Comparison groups
    Period 1 and 2: Placebo v Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3717
    Method
    		 Wilcoxon Rank Sum Test
    Confidence interval

    Secondary: Percentage of time that pH ≥3 and pH ≥4 over 10 minute and 30 minute intervals at each electrode

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    End point title
    		 Percentage of time that pH ≥3 and pH ≥4 over 10 minute and 30 minute intervals at each electrode
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    From 0 to 60 minute (post-dose) on Day 1 of Period 1 and 2
    End point values
    		 Period 1 and 2: Placebo Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects analysed
    14
    13
    Units: Percentage of time (%)
    arithmetic mean (standard deviation)
        Electrode 1 pH ≥3 over >0 - ≤30 min
    99.6 ( 0.4 )
    99.7 ( 0.4 )
        Electrode 2 pH ≥3 over >0 - ≤30 min
    95.9 ( 9.4 )
    97.4 ( 6 )
        Electrode 3 pH ≥3 over >0 - ≤30 min
    32.4 ( 30.8 )
    58.8 ( 27.3 )
        Electrode 4 pH ≥3 over >0 - ≤30 min
    28.9 ( 25.2 )
    63.6 ( 25.6 )
        Electrode 5 pH ≥3 over >0 - ≤30 min
    17.1 ( 13.7 )
    66 ( 25 )
        Electrode 6 pH ≥3 over >0 - ≤30 min
    8.8 ( 10.6 )
    57.8 ( 31.8 )
        Electrode 7 pH ≥3 over >0 - ≤30 min
    5.1 ( 6.4 )
    52.4 ( 30.7 )
        Electrode 8 pH ≥3 over >0 - ≤30 min
    6.2 ( 8.5 )
    45.3 ( 35.9 )
        Electrode 9 pH ≥3 over >0 - ≤30 min
    7.3 ( 14.6 )
    47.6 ( 39.2 )
        Electrode 10 pH ≥3 over >0 - ≤30 min
    9.7 ( 26.3 )
    49.4 ( 36 )
        Electrode 1 pH ≥3 over >30 - ≤60 min
    99.7 ( 0.3 )
    96.7 ( 10.9 )
        Electrode 2 pH ≥3 over >30 - ≤60 min
    95.5 ( 8.3 )
    88.3 ( 25.1 )
        Electrode 3 pH ≥3 over >30 - ≤60 min
    27 ( 34.6 )
    31.5 ( 33.6 )
        Electrode 4 pH ≥3 over >30 - ≤60 min
    15.5 ( 33.2 )
    7 ( 9 )
        Electrode 5 pH ≥3 over >30 - ≤60 min
    13.6 ( 29 )
    9.8 ( 13.9 )
        Electrode 6 pH ≥3 over >30 - ≤60 min
    9.1 ( 23.8 )
    10.5 ( 14.8 )
        Electrode 7 pH ≥3 over >30 - ≤60 min
    11.4 ( 24.7 )
    10.7 ( 18 )
        Electrode 8 pH ≥3 over >30 - ≤60 min
    10.5 ( 22.2 )
    9.8 ( 16.5 )
        Electrode 9 pH ≥3 over >30 - ≤60 min
    8.3 ( 21.2 )
    11.7 ( 19.8 )
        Electrode 10 pH ≥3 over >30 - ≤60 min
    9.8 ( 22.2 )
    12.2 ( 25.7 )
        Electrode 1 pH ≥3 over >0 - ≤10 min
    99 ( 0.9 )
    99.2 ( 1.2 )
        Electrode 2 pH ≥3 over >0 - ≤10 min
    93.3 ( 18.3 )
    99.4 ( 0.4 )
        Electrode 3 pH ≥3 over >0 - ≤10 min
    40.9 ( 33.8 )
    87.2 ( 17.4 )
        Electrode 4 pH ≥3 over >0 - ≤10 min
    43.8 ( 32.6 )
    86.3 ( 12 )
        Electrode 5 pH ≥3 over >0 - ≤10 min
    32.9 ( 29.6 )
    82.4 ( 10 )
        Electrode 6 pH ≥3 over >0 - ≤10 min
    21.3 ( 27.1 )
    70.2 ( 23.3 )
        Electrode 7 pH ≥3 over >0 - ≤10 min
    11.8 ( 19.6 )
    51.6 ( 32 )
        Electrode 8 pH ≥3 over >0 - ≤10 min
    12.6 ( 21 )
    47.5 ( 34.6 )
        Electrode 9 pH ≥3 over >0 - ≤10 min
    9 ( 26.3 )
    52.1 ( 37.8 )
        Electrode 10 pH ≥3 over >0 - ≤10 min
    10 ( 26.1 )
    50.1 ( 33.5 )
        Electrode 1 pH ≥3 over >10 - ≤20 min
    99.4 ( 0.4 )
    99.5 ( 0 )
        Electrode 2 pH ≥3 over >10 - ≤20 min
    95.6 ( 10.2 )
    97 ( 5.6 )
        Electrode 3 pH ≥3 over >10 - ≤20 min
    25.6 ( 32.3 )
    54.5 ( 34.7 )
        Electrode 4 pH ≥3 over >10 - ≤20 min
    23.1 ( 30.9 )
    68.6 ( 36.1 )
        Electrode 5 pH ≥3 over >10 - ≤20 min
    11 ( 18.7 )
    69.6 ( 36.3 )
        Electrode 6 pH ≥3 over >10 - ≤20 min
    3.8 ( 7.2 )
    63.5 ( 40.4 )
        Electrode 7 pH ≥3 over >10 - ≤20 min
    1 ( 2.4 )
    67.2 ( 32.8 )
        Electrode 8 pH ≥3 over >10 - ≤20 min
    2.8 ( 9.4 )
    57.3 ( 39.5 )
        Electrode 9 pH ≥3 over >10 - ≤20 min
    5.7 ( 15.6 )
    57.8 ( 45.1 )
        Electrode 10 pH ≥3 over >10 - ≤20 min
    9.6 ( 26.5 )
    62.6 ( 42.8 )
        Electrode 1 pH ≥3 over >20 - ≤30 min
    99.3 ( 0.4 )
    99.3 ( 0.6 )
        Electrode 2 pH ≥3 over >20 - ≤30 min
    97.7 ( 2.5 )
    94.6 ( 12.7 )
        Electrode 3 pH ≥3 over >20 - ≤30 min
    30.6 ( 39.6 )
    34.2 ( 38.5 )
        Electrode 4 pH ≥3 over >20 - ≤30 min
    19.6 ( 32 )
    35.1 ( 40.6 )
        Electrode 5 pH ≥3 over >20 - ≤30 min
    7.4 ( 15.8 )
    45.2 ( 43.9 )
        Electrode 6 pH ≥3 over >20 - ≤30 min
    1.1 ( 3.4 )
    39 ( 48.8 )
        Electrode 7 pH ≥3 over >20 - ≤30 min
    2.6 ( 6.7 )
    37.7 ( 49.6 )
        Electrode 8 pH ≥3 over >20 - ≤30 min
    3.2 ( 9.6 )
    30.7 ( 47.2 )
        Electrode 9 pH ≥3 over >20 - ≤30 min
    7 ( 18.8 )
    32.5 ( 46.7 )
        Electrode 10 pH ≥3 over >20 - ≤30 min
    9.4 ( 26.6 )
    34.9 ( 43.7 )
        Electrode 1 pH ≥3 over >30 - ≤40 min
    99.4 ( 0.4 )
    98.5 ( 3.1 )
        Electrode 2 pH ≥3 over >30 - ≤40 min
    96.5 ( 6.7 )
    90.6 ( 20.6 )
        Electrode 3 pH ≥3 over >30 - ≤40 min
    25.8 ( 37 )
    32.7 ( 38.6 )
        Electrode 4 pH ≥3 over >30 - ≤40 min
    17.9 ( 35.4 )
    10.6 ( 25.2 )
        Electrode 5 pH ≥3 over >30 - ≤40 min
    11.1 ( 26.9 )
    23.1 ( 36.9 )
        Electrode 6 pH ≥3 over >30 - ≤40 min
    7.2 ( 25.6 )
    25.6 ( 35.5 )
        Electrode 7 pH ≥3 over >30 - ≤40 min
    7.4 ( 26.5 )
    25.7 ( 42 )
        Electrode 8 pH ≥3 over >30 - ≤40 min
    8.1 ( 23.3 )
    22.9 ( 37.3 )
        Electrode 9 pH ≥3 over >30 - ≤40 min
    10.5 ( 28.5 )
    26.5 ( 39.1 )
        Electrode 10 pH ≥3 over >30 - ≤40 min
    12 ( 30.5 )
    21.9 ( 34.3 )
        Electrode 1 pH ≥3 over >40 - ≤50 min
    99.2 ( 0.7 )
    96.3 ( 10.9 )
        Electrode 2 pH ≥3 over >40 - ≤50 min
    95.6 ( 8.4 )
    86.6 ( 30 )
        Electrode 3 pH ≥3 over >40 - ≤50 min
    25.1 ( 39.1 )
    28.2 ( 36.3 )
        Electrode 4 pH ≥3 over >40 - ≤50 min
    16.2 ( 35.5 )
    4.6 ( 6.9 )
        Electrode 5 pH ≥3 over >40 - ≤50 min
    16.3 ( 35.5 )
    4.3 ( 8.8 )
        Electrode 6 pH ≥3 over >40 - ≤50 min
    9.1 ( 26.7 )
    5.1 ( 12 )
        Electrode 7 pH ≥3 over >40 - ≤50 min
    11.5 ( 27.6 )
    5.8 ( 13.4 )
        Electrode 8 pH ≥3 over >40 - ≤50 min
    10.7 ( 27 )
    5.5 ( 12.6 )
        Electrode 9 pH ≥3 over >40 - ≤50 min
    9 ( 26.9 )
    5.6 ( 17.5 )
        Electrode 10 pH ≥3 over >40 - ≤50 min
    7.8 ( 26.5 )
    7.3 ( 23.2 )
        Electrode 1 pH ≥3 over >50 - ≤60 min
    99.5 ( 0.2 )
    94.3 ( 18.5 )
        Electrode 2 pH ≥3 over >50 - ≤60 min
    93.6 ( 16.4 )
    87 ( 28.7 )
        Electrode 3 pH ≥3 over >50 - ≤60 min
    29.7 ( 36.5 )
    33.3 ( 36.9 )
        Electrode 4 pH ≥3 over >50 - ≤60 min
    12.3 ( 29.5 )
    5.8 ( 10.1 )
        Electrode 5 pH ≥3 over >50 - ≤60 min
    13.4 ( 27 )
    1.9 ( 4.3 )
        Electrode 6 pH ≥3 over >50 - ≤60 min
    10.9 ( 21.7 )
    0.8 ( 2.4 )
        Electrode 7 pH ≥3 over >50 - ≤60 min
    15.3 ( 29 )
    0.4 ( 1.3 )
        Electrode 8 pH ≥3 over >50 - ≤60 min
    12.6 ( 28 )
    0.9 ( 3 )
        Electrode 9 pH ≥3 over >50 - ≤60 min
    5.1 ( 11.9 )
    2.9 ( 10 )
        Electrode 10 pH ≥3 over >50 - ≤60 min
    9.5 ( 19 )
    7.3 ( 26.1 )
        Electrode 1 pH ≥4 over >0 - ≤30 min
    99.4 ( 0.6 )
    99.6 ( 0.5 )
        Electrode 2 pH ≥4 over >0 - ≤30 min
    94.9 ( 10.8 )
    97 ( 6.9 )
        Electrode 3 pH ≥4 over >0 - ≤30 min
    28 ( 32.1 )
    54.4 ( 27.5 )
        Electrode 4 pH ≥4 over >0 - ≤30 min
    21.2 ( 25.1 )
    59.2 ( 24.9 )
        Electrode 5 pH ≥4 over >0 - ≤30 min
    10.1 ( 10.6 )
    63.2 ( 24.5 )
        Electrode 6 pH ≥4 over >0 - ≤30 min
    3.4 ( 4.9 )
    55.8 ( 31.6 )
        Electrode 7 pH ≥4 over >0 - ≤30 min
    1.2 ( 1.8 )
    49.3 ( 30.6 )
        Electrode 8 pH ≥4 over >0 - ≤30 min
    1.9 ( 4 )
    42.9 ( 36.1 )
        Electrode 9 pH ≥4 over >0 - ≤30 min
    0.9 ( 1.9 )
    45.8 ( 38.6 )
        Electrode 10 pH ≥4 over >0 - ≤30 min
    3.8 ( 9.6 )
    47.7 ( 35.8 )
        Electrode 1 pH ≥4 over >30 - ≤60 min
    99.6 ( 0.5 )
    95.3 ( 15.8 )
        Electrode 2 pH ≥4 over >30 - ≤60 min
    94 ( 11.4 )
    86.1 ( 27.6 )
        Electrode 3 pH ≥4 over >30 - ≤60 min
    25.1 ( 34.6 )
    26.5 ( 33.8 )
        Electrode 4 pH ≥4 over >30 - ≤60 min
    14.8 ( 32.9 )
    4.4 ( 7.9 )
        Electrode 5 pH ≥4 over >30 - ≤60 min
    9.6 ( 24.3 )
    7.6 ( 12.6 )
        Electrode 6 pH ≥4 over >30 - ≤60 min
    6.3 ( 22.1 )
    7.6 ( 13.7 )
        Electrode 7 pH ≥4 over >30 - ≤60 min
    6.3 ( 22 )
    8.6 ( 15.7 )
        Electrode 8 pH ≥4 over >30 - ≤60 min
    5 ( 18.5 )
    8.1 ( 15.4 )
        Electrode 9 pH ≥4 over >30 - ≤60 min
    5.7 ( 21 )
    9.8 ( 18.8 )
        Electrode 10 pH ≥4 over >30 - ≤60 min
    6.9 ( 20.1 )
    10.5 ( 24.9 )
        Electrode 1 pH ≥4 over >0 - ≤10 min
    98.9 ( 1 )
    99.1 ( 1.5 )
        Electrode 2 pH ≥4 over >0 - ≤10 min
    92.7 ( 19.3 )
    99.3 ( 0.4 )
        Electrode 3 pH ≥4 over >0 - ≤10 min
    35.9 ( 35.9 )
    82.4 ( 19 )
        Electrode 4 pH ≥4 over >0 - ≤10 min
    36.4 ( 34.5 )
    81.8 ( 14.5 )
        Electrode 5 pH ≥4 over >0 - ≤10 min
    25 ( 28 )
    79.7 ( 12.2 )
        Electrode 6 pH ≥4 over >0 - ≤10 min
    8.9 ( 12.6 )
    69 ( 23.1 )
        Electrode 7 pH ≥4 over >0 - ≤10 min
    2.8 ( 4.9 )
    47.2 ( 32.1 )
        Electrode 8 pH ≥4 over >0 - ≤10 min
    5.5 ( 12.1 )
    44.9 ( 35.3 )
        Electrode 9 pH ≥4 over >0 - ≤10 min
    1.1 ( 3.2 )
    36.9 ( 36.9 )
        Electrode 10 pH ≥4 over >0 - ≤10 min
    6.3 ( 17.5 )
    49.2 ( 33.6 )
        Electrode 1 pH ≥4 over >10 - ≤20 min
    99.4 ( 0.4 )
    99.5 ( 0 )
        Electrode 2 pH ≥4 over >10 - ≤20 min
    94.7 ( 12.9 )
    96.4 ( 7.2 )
        Electrode 3 pH ≥4 over >10 - ≤20 min
    21.3 ( 33.9 )
    48.7 ( 36.7 )
        Electrode 4 pH ≥4 over >10 - ≤20 min
    13 ( 26.2 )
    64.1 ( 36 )
        Electrode 5 pH ≥4 over >10 - ≤20 min
    3.3 ( 7.2 )
    67.3 ( 37.4 )
        Electrode 6 pH ≥4 over >10 - ≤20 min
    1.2 ( 3.1 )
    61.2 ( 41.3 )
        Electrode 7 pH ≥4 over >10 - ≤20 min
    0.2 ( 0.7 )
    63 ( 35.1 )
        Electrode 8 pH ≥4 over >10 - ≤20 min
    0 ( 0 )
    53.4 ( 39.7 )
        Electrode 9 pH ≥4 over >10 - ≤20 min
    0 ( 0.2 )
    54.6 ( 44.6 )
        Electrode 10 pH ≥4 over >10 - ≤20 min
    3.8 ( 10.7 )
    60.2 ( 43.2 )
        Electrode 1 pH ≥4 over >20 - ≤30 min
    99 ( 1.1 )
    99.3 ( 0.6 )
        Electrode 2 pH ≥4 over >20 - ≤30 min
    96.3 ( 5.4 )
    94.2 ( 13.4 )
        Electrode 3 pH ≥4 over >20 - ≤30 min
    26.6 ( 38.3 )
    31.6 ( 39.6 )
        Electrode 4 pH ≥4 over >20 - ≤30 min
    14.1 ( 25.7 )
    31.1 ( 40.9 )
        Electrode 5 pH ≥4 over >20 - ≤30 min
    1.8 ( 4.7 )
    41.7 ( 42 )
        Electrode 6 pH ≥4 over >20 - ≤30 min
    0 ( 0 )
    36.5 ( 46.7 )
        Electrode 7 pH ≥4 over >20 - ≤30 min
    0.6 ( 2.3 )
    37.1 ( 48.9 )
        Electrode 8 pH ≥4 over >20 - ≤30 min
    0.1 ( 0.4 )
    30.1 ( 46.6 )
        Electrode 9 pH ≥4 over >20 - ≤30 min
    1.5 ( 5 )
    31.6 ( 46.6 )
        Electrode 10 pH ≥4 over >20 - ≤30 min
    1.4 ( 5.2 )
    33.2 ( 43.9 )
        Electrode 1 pH ≥4 over >30 - ≤40 min
    99.4 ( 0.4 )
    97.4 ( 6.8 )
        Electrode 2 pH ≥4 over >30 - ≤40 min
    95.4 ( 9.5 )
    88.8 ( 23.1 )
        Electrode 3 pH ≥4 over >30 - ≤40 min
    23.6 ( 36.9 )
    26.9 ( 38.3 )
        Electrode 4 pH ≥4 over >30 - ≤40 min
    17.4 ( 35.4 )
    9.3 ( 24.6 )
        Electrode 5 pH ≥4 over >30 - ≤40 min
    9.1 ( 25.9 )
    20.7 ( 36.1 )
        Electrode 6 pH ≥4 over >30 - ≤40 min
    6.4 ( 22.6 )
    19.8 ( 34.2 )
        Electrode 7 pH ≥4 over >30 - ≤40 min
    7.1 ( 26.4 )
    21.6 ( 37.7 )
        Electrode 8 pH ≥4 over >30 - ≤40 min
    5.6 ( 20.6 )
    18.8 ( 34.4 )
        Electrode 9 pH ≥4 over >30 - ≤40 min
    7.2 ( 26.6 )
    21.7 ( 35.4 )
        Electrode 10 pH ≥4 over >30 - ≤40 min
    5.5 ( 20.5 )
    17.6 ( 30.2 )
        Electrode 1 pH ≥4 over >40 - ≤50 min
    99 ( 1.4 )
    94.4 ( 17.9 )
        Electrode 2 pH ≥4 over >40 - ≤50 min
    93.9 ( 11 )
    84 ( 32.1 )
        Electrode 3 pH ≥4 over >40 - ≤50 min
    23.3 ( 38.9 )
    23.7 ( 35.2 )
        Electrode 4 pH ≥4 over >40 - ≤50 min
    15.3 ( 35.7 )
    1.7 ( 2.2 )
        Electrode 5 pH ≥4 over >40 - ≤50 min
    12.1 ( 29.5 )
    1.4 ( 3.4 )
        Electrode 6 pH ≥4 over >40 - ≤50 min
    7.3 ( 26.6 )
    2.9 ( 7.9 )
        Electrode 7 pH ≥4 over >40 - ≤50 min
    7.1 ( 26.6 )
    4 ( 10 )
        Electrode 8 pH ≥4 over >40 - ≤50 min
    7.1 ( 26.6 )
    4.8 ( 11.8 )
        Electrode 9 pH ≥4 over >40 - ≤50 min
    7.2 ( 26.6 )
    5.2 ( 16.8 )
        Electrode 10 pH ≥4 over >40 - ≤50 min
    7.4 ( 26 )
    6.7 ( 22.9 )
        Electrode 1 pH ≥4 over >50 - ≤60 min
    99.4 ( 0.4 )
    93.1 ( 22.4 )
        Electrode 2 pH ≥4 over >50 - ≤60 min
    91.8 ( 19.5 )
    84.7 ( 29.9 )
        Electrode 3 pH ≥4 over >50 - ≤60 min
    28.2 ( 36.3 )
    28.5 ( 37 )
        Electrode 4 pH ≥4 over >50 - ≤60 min
    11.5 ( 28.3 )
    2.2 ( 2.7 )
        Electrode 5 pH ≥4 over >50 - ≤60 min
    7.5 ( 18.5 )
    0.7 ( 2.4 )
        Electrode 6 pH ≥4 over >50 - ≤60 min
    5.2 ( 16.9 )
    0.1 ( 0.2 )
        Electrode 7 pH ≥4 over >50 - ≤60 min
    4.6 ( 13.1 )
    0.1 ( 0.2 )
        Electrode 8 pH ≥4 over >50 - ≤60 min
    2.3 ( 8 )
    0.8 ( 2.8 )
        Electrode 9 pH ≥4 over >50 - ≤60 min
    2.7 ( 9.5 )
    2.5 ( 9.1 )
        Electrode 10 pH ≥4 over >50 - ≤60 min
    7.7 ( 16.7 )
    7 ( 25 )
    No statistical analyses for this end point

    Secondary: Number of subjects with Adverse Events (AEs)

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    End point title
    		 Number of subjects with Adverse Events (AEs)
    End point description
    Safety population. TEAE = Treatment Emergent Adverse Event SAE = Serious Adverse Event
    End point type
    Secondary
    End point timeframe
    Up to follow-up (Day 7, Period 2)
    End point values
    		 Period 1 and 2: Placebo Period 1 and 2: Gaviscon Double Action Liquid Sachets 20 ml
    Number of subjects analysed
    14
    13
    Units: Participants
        Any TEAE
    3
    0
        Any SAE
    0
    0
        Discontinued due to AE
    0
    0
        AE of mild intensity
    2
    0
        AE of moderate intensity
    1
    0
        AE of severe intensity
    0
    0
        Possibly related AE
    1
    0
        Unlikely related AE
    0
    0
        Unrelated AE
    2
    0
    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, Period 2)
    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
    18.0
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (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
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 15 (20.00%)
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1

    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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    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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