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    Clinical Trial Results:
    A multi-centre, randomised, double-blind, two arm, parallel group, placebo-controlled study to assess the effect of Sodium Alginate Chewable Tablets on symptoms of gastro-oesophageal reflux disease.

    Summary
    EudraCT number
    		 2014-005261-69
    Trial protocol
    		 GB   DE   IT  
    Global end of trial date
    30 Aug 2016

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

    Trial information

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    Trial identification
    Sponsor protocol code
    GA1402
    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
    07 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the efficacy of Sodium Alginate Chewable Tablets compared to matched placebo tablets in the reduction of the symptoms of GORD as assessed using the Reflux Disease Questionnaire (RDQ).
    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
    21 Sep 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
    United Kingdom: 93
    Country: Number of subjects enrolled
    Germany: 288
    Country: Number of subjects enrolled
    Italy: 43
    Worldwide total number of subjects
    424
    EEA total number of subjects
    424
    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)
    333
    From 65 to 84 years
    88
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited at sites in the United Kingdom, Germany and Italy.

    Pre-assignment
    Screening details
    		 Total 526 subjects were screened; 99 subjects were screening failures; 427 subjects were randomized & 426 subjects were treated (1 subject was randomized in error). Subject included in analysis were 424 (2 lost to follow-up subjects from both groups were also excluded from analysis due to no treatment evidence & evaluable data for any visits).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Gaviscon
    Arm description
    		 Gaviscon Double Action Tablets, 4 tablets by mouth 4 times daily for 7 - 10 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gaviscon Double Action Tablets
    Investigational medicinal product code
    Other name
    Sodium alginate chewable tablets
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Gaviscon Double Action Tablets, 4 tablets by mouth 4 times daily for 7 - 10 days

    Arm title
    		 Placebo
    Arm description
    		 Placebo (matching tablets) 4 tablets 4 times daily for 7 - 10 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo (matching tablets), 4 tablets 4 times daily for 7 - 10 days

    Number of subjects in period 1
    		Gaviscon Placebo
    Started
    212
    212
    Completed
    200
    199
    Not completed
    12
    13
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    9
    9
         Lack of efficacy
    1
    2
         Protocol deviation
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gaviscon
    Reporting group description
    		 Gaviscon Double Action Tablets, 4 tablets by mouth 4 times daily for 7 - 10 days

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (matching tablets) 4 tablets 4 times daily for 7 - 10 days

    Reporting group values
    		 Gaviscon Placebo Total
    Number of subjects
    		 212 212 424
    Age categorical
    ITT population
    Units: Subjects
        Adults (18-64 years)
    		 172 161 333
        From 65-84 years
    		 38 50 88
        85 years and over
    		 2 1 3
    Age continuous
    ITT population
    Units: years
        arithmetic mean (standard deviation)
    		 50 ± 15.51 50.1 ± 16.47 -
    Gender categorical
    ITT population
    Units: Subjects
        Female
    		 110 115 225
        Male
    		 102 97 199
    Ethnicity
    ITT population
    Units: Subjects
        Asian
    		 2 2 4
        Black or African American
    		 1 1 2
        Other
    		 0 0 0
        White
    		 209 209 418
    Smoking history
    ITT population
    Units: Subjects
        Current smoker
    		 45 46 91
        Ex-smoker
    		 58 52 110
        Never smoked
    		 109 114 223
    Alcohol consumer
    ITT population
    Units: Subjects
        No
    		 91 107 198
        Yes
    		 121 105 226
    Height
    ITT population
    Units: cm
        arithmetic mean (standard deviation)
    		 171.3 ± 9.39 170.1 ± 10.32 -
    Weight
    ITT population
    Units: kg
        arithmetic mean (standard deviation)
    		 82.2 ± 18.07 80.2 ± 17.56 -

    End points

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    End points reporting groups
    Reporting group title
    Gaviscon
    Reporting group description
    		 Gaviscon Double Action Tablets, 4 tablets by mouth 4 times daily for 7 - 10 days

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (matching tablets) 4 tablets 4 times daily for 7 - 10 days

    Primary: Number of subjects with a reduction of at least 1.5 points in the RDQ GORD dimension from baseline

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    End point title
    		 Number of subjects with a reduction of at least 1.5 points in the RDQ GORD dimension from baseline
    End point description
    Intent-to-treat (ITT) population: All randomized subjects (minus three subjects with no evaluable data). Reflux Disease Questionnaire (RDQ) is a validated 12-item self-assessment questionnaire in which subjects are asked to rate the frequency and severity of 6 symptoms covering the two dimensions of Gastro-Oesophageal Reflux Disease (GORD) – regurgitation and heartburn – and dyspepsia on 6-point Likert scales ranging from 0 = None to 5 = Daily and 0 = none to 5 = Severe, respectively. Response = Reduction of RDQ GORD dimension score ≥1.5. Responder = Subject with a reduction from baseline of 1.5 points in the RDQ GORD dimension score.
    End point type
    Primary
    End point timeframe
    Visit 2 (baseline) to visit 3
    End point values
    		 Gaviscon Placebo
    Number of subjects analysed
    212
    212
    Units: Participants
        Non-responders
    101
    132
        Responders
    111
    80
    Statistical analysis title
    		 RDQ GORD responses
    Statistical analysis description
    Number of subjects with a reduction of at least 1.5 points in the RDQ GORD dimension from baseline
    Comparison groups
    Gaviscon v Placebo
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0031
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline in RDQ GORD dimension score

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    End point title
    		 Change from baseline in RDQ GORD dimension score
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    Visit 2 (baseline) to visit 3
    End point values
    		 Gaviscon Placebo
    Number of subjects analysed
    212
    212
    Units: Participants
    arithmetic mean (standard deviation)
        Baseline (Visit 2)
    3.1 ± 0.93
    3 ± 0.9
        End of treatment (Visit 3)
    1.4 ± 1.2
    1.7 ± 1.21
        Change from Baseline
    -1.7 ± 1.27
    -1.3 ± 1.16
    Statistical analysis title
    		 RDQ GORD dimension score
    Comparison groups
    Gaviscon v Placebo
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline in RDQ heartburn score

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    End point title
    		 Change from baseline in RDQ heartburn score
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    Visit 2 (baseline) to visit 3
    End point values
    		 Gaviscon Placebo
    Number of subjects analysed
    212
    212
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline (Visit 2)
    3 ± 1.29
    2.9 ± 1.19
        End of treatment (Visit 3)
    1.5 ± 1.37
    1.8 ± 1.41
        Change from Baseline
    -1.6 ± 1.58
    -1.2 ± 1.36
    Statistical analysis title
    		 RDQ heartburn score
    Comparison groups
    Gaviscon v Placebo
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.019
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline in RDQ regurgitation score

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    End point title
    		 Change from baseline in RDQ regurgitation score
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    Visit 2 (baseline) to visit 3
    End point values
    		 Gaviscon Placebo
    Number of subjects analysed
    212
    212
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline (Visit 2)
    3.1 ± 1.16
    3.1 ± 1.19
        End of treatment (Visit 3)
    1.3 ± 1.4
    1.7 ± 1.39
        Change from Baseline
    -1.8 ± 1.45
    -1.5 ± 1.45
    Statistical analysis title
    		 RDQ regurgitation score
    Comparison groups
    Gaviscon v Placebo
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.029
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline in RDQ dyspepsia score

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    End point title
    		 Change from baseline in RDQ dyspepsia score
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    Visit 2 (baseline) to visit 3
    End point values
    		 Gaviscon Placebo
    Number of subjects analysed
    212
    212
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline (Visit 2)
    2.6 ± 1.41
    2.5 ± 1.29
        End of treatment (Visit 3)
    1.3 ± 1.36
    1.6 ± 1.41
        Change from Baseline
    -1.4 ± 1.51
    -1 ± 1.44
    Statistical analysis title
    		 RDQ dyspepsia score
    Comparison groups
    Gaviscon v Placebo
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Overall Treatment Evaluation (OTE)

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    End point title
    		 Overall Treatment Evaluation (OTE)
    End point description
    ITT population. OTE questionnaire is a validated scale which asks subjects to rate the degree of changes in their symptoms after 7 days of drug administration on a 15-point Likert-scale ranging from -7 = Extremely deteriorated to +7 = Extremely improved. In case of change, subjects are asked to rate the importance of the change on a 7-point scale ranging from 1 = Not important to 7 = Extremely important.
    End point type
    Secondary
    End point timeframe
    Visit 2 (baseline) to visit 3
    End point values
    		 Gaviscon Placebo
    Number of subjects analysed
    212
    212
    Units: Participants
        -7 extremely deteriorated
    1
    4
        -6 significantly deteriorated
    2
    4
        -5 relatively deteriorated
    4
    6
        -4 moderately deteriorated
    1
    4
        -3 a little deteriorated
    1
    5
        -2 slightly deteriorated
    4
    3
        -1 almost not deteriorated
    1
    2
        0 no change
    34
    37
        +1 almost not improved
    12
    16
        +2 slightly improved
    24
    17
        +3 a little improved
    13
    25
        +4 moderately improved
    21
    26
        +5 relatively improved
    27
    29
        +6 significantly improved
    39
    25
        +7 extremely improved
    26
    7
    No statistical analyses for this end point

    Secondary: Change from baseline in number of nights (out of the last 7 nights) when the subject experienced night time symptoms

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    End point title
    		 Change from baseline in number of nights (out of the last 7 nights) when the subject experienced night time symptoms
    End point description
    ITT population. Before treatment, subjects were asked as to how many nights over the last 7 nights they had experienced night time symptoms (‘How many nights did you have night time symptoms over the last 7 nights?’). The answer was documented in the eCRF. During the treatment period, subjects recorded night time symptoms in the subject diary, prompted by the question ‘Did you have any night time symptoms last night?’ The number of nights with night time symptoms during treatment was calculated from these data.
    End point type
    Secondary
    End point timeframe
    Visit 2 (baseline) to visit 3
    End point values
    		 Gaviscon Placebo
    Number of subjects analysed
    212
    212
    Units: Night
    arithmetic mean (standard deviation)
        Baseline (Visit 2)
    4 ± 2.67
    3.9 ± 2.55
        End of treatment (Visit 3)
    1.7 ± 2.2
    1.7 ± 2.13
    No statistical analyses for this end point

    Secondary: Change from baseline in subject ratings of the degree (magnitude) and the importance of changes in symptoms

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    End point title
    		 Change from baseline in subject ratings of the degree (magnitude) and the importance of changes in symptoms
    End point description
    ITT population. 'Symptom change after 7 days administration' ranged from -7 = Extremely deteriorated over 0 = No change to +7 = Extremely improved. 'Importance of symptom change to subject' ranged from 0 = No improvement to 7 = extremely important.
    End point type
    Secondary
    End point timeframe
    Visit 2 (baseline) to visit 3
    End point values
    		 Gaviscon Placebo
    Number of subjects analysed
    212
    212
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Symptom change after 7 days administration
    3.2 ± 3.08
    2.2 ± 3.34
        Importance of symptom change for subject
    4 ± 2.6
    3.5 ± 2.72
    Statistical analysis title
    		 Symptom change after 7 days administration
    Comparison groups
    Gaviscon v Placebo
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 two-sided Wilcoxon two-sample test
    Confidence interval
    Statistical analysis title
    		 Importance of symptom change for subject
    Comparison groups
    Gaviscon v Placebo
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.068
    Method
    		 two-sided Wilcoxon two-sample test
    Confidence interval

    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. ADR = Adverse Drug Reaction SAE = Serious Adverse Event
    End point type
    Secondary
    End point timeframe
    Up to Visit 3
    End point values
    		 Gaviscon Placebo
    Number of subjects analysed
    212
    212
    Units: Participants
        All Adverse Events (AEs):
    109
    115
        Non-treatment emergent adverse events:
    12
    14
        Treatment emergent adverse events (TEAEs):
    104
    107
        IMP-related adverse events (ADRs):
    66
    54
        Serious TEAEs (SAEs):
    0
    1
        IMP-related serious TEAEs (serious ADRs):
    0
    0
        TEAEs with death as outcome:
    0
    0
        TEAEs leading to dose withdrawal:
    9
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Visit 3
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Gaviscon
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Gaviscon Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 212 (0.00%)
    1 / 212 (0.47%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 212 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 212 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Gaviscon Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    104 / 212 (49.06%)
    107 / 212 (50.47%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    28 / 212 (13.21%)
    30 / 212 (14.15%)
         occurrences all number
    29
    31
    Gastrointestinal disorders
    Flatulence
         subjects affected / exposed
    36 / 212 (16.98%)
    37 / 212 (17.45%)
         occurrences all number
    37
    38
    Diarrhoea
         subjects affected / exposed
    23 / 212 (10.85%)
    17 / 212 (8.02%)
         occurrences all number
    23
    17
    Nausea
         subjects affected / exposed
    16 / 212 (7.55%)
    20 / 212 (9.43%)
         occurrences all number
    17
    21
    Abdominal pain upper
         subjects affected / exposed
    17 / 212 (8.02%)
    18 / 212 (8.49%)
         occurrences all number
    18
    25

    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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