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    Clinical Trial Results:
    A multicentre, randomised, double-blind, two arm, parallel group, placebo controlled, pilot study to assess the effect of Gaviscon Advance as add-on therapy in GORD patients with inadequate response to once daily proton pump inhibitor treatment.

    Summary
    EudraCT number
    		 2011-005486-21
    Trial protocol
    		 DK   DE  
    Global end of trial date
    14 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jun 2017
    First version publication date
    11 Jun 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GA1102
    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
    Medical Director, Gastroenterology, Clearcut Clinical Consulting Ltd., +44 7813731925,
    Scientific contact
    Medical Director, Gastroenterology, Clearcut Clinical Consulting Ltd., +44 7813731925,
    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
    09 Apr 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Nov 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to assess the efficacy of Gaviscon Advance (an aniseed flavoured oral suspension) compared with placebo in the suppression of GORD symptoms in patients whose symptoms are inadequately controlled by once daily PPI therapy alone.
    Protection of trial subjects
    This study was conducted in accordance with ICH Good Clinical Practice 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
    20 Jun 2012
    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
    Denmark: 74
    Country: Number of subjects enrolled
    Germany: 62
    Worldwide total number of subjects
    136
    EEA total number of subjects
    136
    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)
    94
    From 65 to 84 years
    41
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was multicentre and multinational with 8 active centres in Denmark and Germany.

    Pre-assignment
    Screening details
    		 A total of 195 patients were screened for the study, of which 59 patients were screen failures and 136 patients were randomized.

    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 Advance
    Arm description
    		 Gaviscon Advance 10 ml taken 4 times a day for 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gaviscon Advance
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    10 ml taken 4 times a day for 7 days.

    Arm title
    		 Placebo
    Arm description
    		 Placebo 10 ml taken 4 times a day for 7 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    10 ml taken 4 times a day for 7 days.

    Number of subjects in period 1
    		Gaviscon Advance Placebo
    Started
    66
    70
    Completed
    65
    68
    Not completed
    1
    2
         Adverse Event
    1
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gaviscon Advance
    Reporting group description
    		 Gaviscon Advance 10 ml taken 4 times a day for 7 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo 10 ml taken 4 times a day for 7 days.

    Reporting group values
    		 Gaviscon Advance Placebo Total
    Number of subjects
    		 66 70 136
    Age categorical
    Safety Population: All patients who were recruited to the study and received at least one dose of IMP. This population was used for summaries of safety and also for baseline data.
    Units: Subjects
        Adults (18-64 years)
    		 44 50 94
        From 65-84 years
    		 21 20 41
        85 years and over
    		 1 0 1
    Age continuous
    Safety population
    Units: years
        arithmetic mean (standard deviation)
    		 57.4 ( 13.97 ) 55.4 ( 14.79 ) -
    Gender categorical
    Safety population
    Units: Subjects
        Female
    		 42 46 88
        Male
    		 24 24 48
    Ethnicity
    Safety population
    Units: Subjects
        Caucasian
    		 66 68 134
        Asian
    		 0 2 2
    Smoking habits
    Safety population
    Units: Subjects
        Never
    		 37 29 66
        Former
    		 17 26 43
        Current
    		 12 15 27
    Alcohol consumption
    Safety population
    Units: Subjects
        Never
    		 37 36 73
        Former
    		 1 3 4
        Current
    		 28 31 59
    Caffeine consumption
    Safety population
    Units: Subjects
        Never
    		 5 12 17
        Former
    		 2 1 3
        Current
    		 59 57 116
    Height
    Safety population
    Units: cm
        arithmetic mean (standard deviation)
    		 170 ( 11.07 ) 169.8 ( 9.45 ) -
    Weight
    Safety population
    Units: kg
        arithmetic mean (standard deviation)
    		 81.6 ( 17.25 ) 81 ( 20.35 ) -
    BMI
    Safety population
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 28.13 ( 4.855 ) 27.99 ( 6.454 ) -

    End points

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    End points reporting groups
    Reporting group title
    Gaviscon Advance
    Reporting group description
    		 Gaviscon Advance 10 ml taken 4 times a day for 7 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo 10 ml taken 4 times a day for 7 days.

    Primary: Change from Baseline to Post-Dose in HRDQ score (heartburn and regurgitation only)

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    End point title
    		 Change from Baseline to Post-Dose in HRDQ score (heartburn and regurgitation only)
    End point description
    Intention to treat (ITT) population: All patients who were recruited to the study and had at least 1 day of complete HRDQ (Heartburn and Dyspesia) data post-dosing. This population was used for summaries of efficacy and baseline data. Two patients with no post-baseline HRDQ data were excluded from ITT population. Heartburn Regurgitation and Dyspepsia Questionnaire (HRDQ): The HRDQ symptom severity was recorded a 0 (no symptoms), 1 (mild), 2 (moderate) and 3 (severe) and the frequency was scored as 0 (none), 1 (once), 2 (twice), 3 (thrice), 4 (4 or 5 times), 5 (6 – 10 times) and 6 (more than 10 times or constant). In addition, the HRDQ questionnaire required patients to record the duration of their symptoms and whether or not they had experienced night-time symptoms.
    End point type
    Primary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Gaviscon Advance Placebo
    Number of subjects analysed
    65
    69
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change from baseline to post-dose
    -4.95 ( 4.69 )
    -3.48 ( 5.51 )
    Statistical analysis title
    		 Change in HRDQ Score (heartburn and regurgitation)
    Statistical analysis description
    Intention to treat (ITT) population: All patients who were recruited to the study and had at least 1 day of complete HRDQ (Heartburn and Dyspesia) data post-dosing. This population was used for summaries of efficacy and baseline data. Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
    Comparison groups
    Gaviscon Advance v Placebo
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0321
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in HRDQ Score – Dyspepsia

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    End point title
    		 Change in HRDQ Score – Dyspepsia
    End point description
    ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Gaviscon Advance Placebo
    Number of subjects analysed
    65
    69
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change from baseline to post-dose
    -1.68 ( 2.98 )
    -1.08 ( 3.21 )
    Statistical analysis title
    		 Change in HRDQ Score – Dyspepsia
    Statistical analysis description
    ITT population. Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
    Comparison groups
    Gaviscon Advance v Placebo
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4845
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in HRDQ Score – Heartburn

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    End point title
    		 Change in HRDQ Score – Heartburn
    End point description
    ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Gaviscon Advance Placebo
    Number of subjects analysed
    65
    69
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change from baseline to post-dose
    -2.74 ( 2.56 )
    -1.9 ( 3.27 )
    Statistical analysis title
    		 Change in HRDQ Score – Heartburn
    Statistical analysis description
    Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
    Comparison groups
    Gaviscon Advance v Placebo
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0244
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in HRDQ Score – Regurgitation

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    End point title
    		 Change in HRDQ Score – Regurgitation
    End point description
    ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Gaviscon Advance Placebo
    Number of subjects analysed
    65
    69
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change from baseline to post-dose
    -2.2 ( 2.53 )
    -1.55 ( 2.71 )
    Statistical analysis title
    		 Change in HRDQ Score – Regurgitation
    Statistical analysis description
    Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
    Comparison groups
    Gaviscon Advance v Placebo
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1045
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline to Post-Dose in Number of Days with Night Time Symptoms

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    End point title
    		 Change From Baseline to Post-Dose in Number of Days with Night Time Symptoms
    End point description
    ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Gaviscon Advance Placebo
    Number of subjects analysed
    65
    69
    Units: Number of days
    arithmetic mean (standard deviation)
        Change from baseline to post-dose
    -1.66 ( 2.56 )
    -0.6 ( 1.74 )
    Statistical analysis title
    		 Change in Number of Days with Night Time Symptoms
    Comparison groups
    Gaviscon Advance v Placebo
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0083
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline to Post-Dose in Duration of Symptoms (HRDQ)

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    End point title
    		 Change From Baseline to Post-Dose in Duration of Symptoms (HRDQ)
    End point description
    ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Gaviscon Advance Placebo
    Number of subjects analysed
    64
    68
    Units: minute
    arithmetic mean (standard deviation)
        Change from baseline to post-dose
    -73.58 ( 222.57 )
    -66.92 ( 201.44 )
    Statistical analysis title
    		 Change in Duration of Symptoms
    Comparison groups
    Gaviscon Advance v Placebo
    Number of subjects included in analysis
    132
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6494
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline to Post-Dose in Frequency of Heartburn (HRDQ Score)

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    End point title
    		 Change From Baseline to Post-Dose in Frequency of Heartburn (HRDQ Score)
    End point description
    ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Gaviscon Advance Placebo
    Number of subjects analysed
    65
    69
    Units: Number of events
    arithmetic mean (standard deviation)
        Change from baseline to post-dose
    -1.21 ( 1.06 )
    -0.78 ( 1.14 )
    Statistical analysis title
    		 Change in Duration of Symptoms
    Statistical analysis description
    Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
    Comparison groups
    Gaviscon Advance v Placebo
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0114
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline to Post-Dose in Frequency of Regurgitation (HRDQ Score)

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    End point title
    		 Change From Baseline to Post-Dose in Frequency of Regurgitation (HRDQ Score)
    End point description
    ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Gaviscon Advance Placebo
    Number of subjects analysed
    65
    69
    Units: Number of events
    arithmetic mean (standard deviation)
        Change from baseline to post-dose
    -1.03 ( 1.08 )
    -0.63 ( 1.19 )
    Statistical analysis title
    		 Change in Frequency of Regurgitation
    Statistical analysis description
    Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
    Comparison groups
    Gaviscon Advance v Placebo
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0364
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline to Post-Dose in Frequency of Dyspepsia (HRDQ Score)

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    End point title
    		 Change From Baseline to Post-Dose in Frequency of Dyspepsia (HRDQ Score)
    End point description
    ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Gaviscon Advance Placebo
    Number of subjects analysed
    65
    69
    Units: Number of events
    arithmetic mean (standard deviation)
        Change from baseline to post-dose
    -0.83 ( 1.23 )
    -0.48 ( 1.22 )
    Statistical analysis title
    		 Change in Frequency of Dyspepsia
    Statistical analysis description
    Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
    Comparison groups
    Placebo v Gaviscon Advance
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1857
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline to Post-Dose in ReQuest GI Scores

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    End point title
    		 Change From Baseline to Post-Dose in ReQuest GI Scores
    End point description
    ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population. ReQuest GI is a self-assessed, dimension-orientated scale designed to evaluate treatment response on a daily basis in patients suffering from GORD. The scale assesses 4 dimensions of GORD. Intensity is measured on a 100-mm VAS and frequency on a 7-point Likert scale (0 to 10 times/constant per day). The range of the ReQuest™ GI score is from 0 reflecting no symptoms to 30.77 reflecting the highest severity/frequency of symptoms.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Gaviscon Advance Placebo
    Number of subjects analysed
    58
    61
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change from baseline to post-dose
    -2.8 ( 3.3 )
    -2.37 ( 3.49 )
    Statistical analysis title
    		 Change in ReQuest GI scores
    Statistical analysis description
    Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
    Comparison groups
    Gaviscon Advance v Placebo
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3138
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline to Post-Dose in the Patient Satisfaction Score

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    End point title
    		 Change From Baseline to Post-Dose in the Patient Satisfaction Score
    End point description
    ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population. Patient Satisfaction Visual Analogue Scale (VAS): Patient satisfaction with IMP in controlling their symptoms was assessed in response to the question: 'Thinking back over the past 7 days and the medication you received, how satisfied are you with the control of your symptoms?' Patients drew a perpendicular line on a 100-mm VAS, with anchors at 0 = 'Very Satisfied' and 100 = 'Very Dissatisfied' to reflect their satisfaction.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Gaviscon Advance Placebo
    Number of subjects analysed
    64
    67
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change from baseline to post-dose
    -2.6 ( 3.18 )
    -2.1 ( 3.01 )
    Statistical analysis title
    		 Change in Patient Satisfaction Score
    Comparison groups
    Gaviscon Advance v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1959
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in Number of Symptom-Free Days (HRDQ)

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    End point title
    		 Change From Baseline in Number of Symptom-Free Days (HRDQ)
    End point description
    ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population. A symptom-free day is defined as a day where the respective symptoms: heartburn, regurgitation and dyspepsia (all derived from the HRDQ) had a value for frequency of 0.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Gaviscon Advance Placebo
    Number of subjects analysed
    65
    69
    Units: day
    arithmetic mean (standard deviation)
        Change from baseline to post-dose
    0.71 ( 1.27 )
    0.61 ( 1.71 )
    Statistical analysis title
    		 Change Number of Symptom Free Days (HRDQ)
    Statistical analysis description
    Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
    Comparison groups
    Gaviscon Advance v Placebo
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9363
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in Number of Symptom-Free Days (ReQuest)

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    End point title
    		 Change From Baseline in Number of Symptom-Free Days (ReQuest)
    End point description
    ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population. ReQuest GI is a self-assessed, dimension-orientated scale designed to evaluate treatment response on a daily basis in patients suffering from GORD. The scale assesses 4 dimensions of GORD. Intensity is measured on a 100-mm VAS and frequency on a 7-point Likert scale (0 to 10 times/constant per day). The range of the ReQuest™ GI score is from 0 reflecting no symptoms to 30.77 reflecting the highest severity/frequency of symptoms. A symptom-free day is defined as a day where the respective symptoms: acid complaints, upper abdominal/stomach complaints, lower abdominal/digestive complaints and nausea (all derived from ReQuest™) had a value for frequency of 0.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Gaviscon Advance Placebo
    Number of subjects analysed
    62
    68
    Units: day
    arithmetic mean (standard deviation)
        Change from baseline to post-dose
    0.55 ( 1.68 )
    0.56 ( 1.49 )
    Statistical analysis title
    		 Change in Number of Symptom Free Days (ReQuest)
    Comparison groups
    Gaviscon Advance v Placebo
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8195
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline to post-dose in whether the patient had any night-time symptoms (HRDQ)

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    End point title
    		 Change from baseline to post-dose in whether the patient had any night-time symptoms (HRDQ)
    End point description
    ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population. -1 = Improvement in night time symptoms (i.e. patients had night-time symptoms at baseline and no night time symptoms post-dose) 0 = Either night-time symptoms at baseline and post-dose or no night-time symptoms at baseline and post-dose 1 = Deterioration in night-time symptoms (i.e. patients had no night-time symptoms at baseline and night time symptoms post-dose)
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
    End point values
    		 Gaviscon Advance Placebo
    Number of subjects analysed
    65
    69
    Units: Number of patients
        -1: Improvement in night-time symptoms
    16
    8
        0: No night-time symptoms at baseline & post-dose
    47
    58
        1: Deterioration in night-time symptoms
    2
    3
    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
    Adverse event reporting additional description
    There were no deaths, other SAEs in this study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Gaviscon Advance
    Reporting group description
    		 Gaviscon Advance 10 ml taken 4 times a day for 7 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo 10 ml taken 4 times a day for 7 days.

    Serious adverse events
    		 Gaviscon Advance Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 70 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Gaviscon Advance Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 66 (24.24%)
    17 / 70 (24.29%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Medication error
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Surgical and medical procedures
    Therapy change
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 70 (0.00%)
         occurrences all number
    4
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    2
    Headache
         subjects affected / exposed
    4 / 66 (6.06%)
    3 / 70 (4.29%)
         occurrences all number
    4
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Constipation
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 66 (3.03%)
    1 / 70 (1.43%)
         occurrences all number
    2
    1
    Dyspepsia
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 70 (0.00%)
         occurrences all number
    2
    0
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Hypoaesthesia oral
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    3 / 66 (4.55%)
    6 / 70 (8.57%)
         occurrences all number
    3
    6
    Vomiting
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 66 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    2
    Pharyngitis
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jul 2012
    1. Clarification of ambiguities in the inclusion criteria 2. Change to SAE reporting procedures according to latest RB SOP 3. Increase in the number of potential sites in Denmark 4. Set up of sites in Germany
    14 Nov 2012
    1. Clarification of ambiguities in the inclusion/exclusion criteria at the request of the German CA (BfArM) and the German leading EC. 2. Change in the procedure for reporting incorrect dosing and pregnancy in accordance with the latest RB protocol template (which complied with regulatory requirements).

    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
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