Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

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

    Summary
    EudraCT number
    		 2014-003174-17
    Trial protocol
    		 GB  
    Global end of trial date
    24 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Nov 2017
    First version publication date
    19 Nov 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GA1405
    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
    17 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Dec 2015
    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 liquid suspension compared with matched placebo liquid 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 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
    28 Apr 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 227
    Country: Number of subjects enrolled
    Germany: 169
    Worldwide total number of subjects
    396
    EEA total number of subjects
    396
    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)
    106
    From 65 to 84 years
    290
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study was conducted in 19 primary care sites in the United Kingdom (UK) and Germany.

    Pre-assignment
    Screening details
    		 A total of 396 patients were screened for the study; 371 patients entered the run-in period and 133 patients were discontinued prior to randomization. Randomized subjects were 263. One subject from placebo group was lost to follow-up. This subject was excluded from ITT population as it is unknown whether any medication was taken by this subject.

    Pre-assignment period milestones
    Number of subjects started
    		 396
    Intermediate milestone: Number of subjects
    Run-in period: 371
    Number of subjects completed
    		 263

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen failure: 133
    Period 1
    Period 1 title
    Overall (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® Double Action Liquid
    Arm description
    		 Gaviscon® Double Action 20 ml (2 x 10 ml) liquid sachets by mouth 4 times a day for 7 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gaviscon® Double Action Liquid
    Investigational medicinal product code
    Other name
    sodium alginate liquid suspension
    Pharmaceutical forms
    Oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Gaviscon® Double Action (sodium alginate 1000 mg, sodium bicarbonate 426 mg and calcium carbonate 650 mg) 20 ml (2 x 10 ml) liquid sachets by mouth 4 times a day for 7 days

    Arm title
    		 Placebo
    Arm description
    		 Placebo 20 ml (2 x 10 ml) liquid sachets by mouth 4 times a day for 7 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Matched placebo liquid
    Pharmaceutical forms
    Oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo 20 ml (2 x 10 ml) liquid sachets by mouth 4 times a day for 7 days

    Number of subjects in period 1 [1]
    		Gaviscon® Double Action Liquid Placebo
    Started
    131
    132
    Completed
    128
    130
    Not completed
    3
    2
         Adverse event
    3
    1
         Lost to follow-up
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 396 patients were screened for the study; 371 patients entered the run-in period and 133 patients were discontinued prior to randomization. Randomized subjects were 263.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Gaviscon® Double Action Liquid
    Reporting group description
    		 Gaviscon® Double Action 20 ml (2 x 10 ml) liquid sachets by mouth 4 times a day for 7 days

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo 20 ml (2 x 10 ml) liquid sachets by mouth 4 times a day for 7 days

    Reporting group values
    		 Gaviscon® Double Action Liquid Placebo Total
    Number of subjects
    		 131 132 263
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 27 32 59
        From 65-84 years
    		 104 100 204
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.28 ( 12.62 ) 52.36 ( 14.41 ) -
    Gender categorical
    Units: Subjects
        Female
    		 82 76 158
        Male
    		 49 56 105
    Race
    Units: Subjects
        Caucasian (White)
    		 129 132 261
        Asian
    		 2 0 2
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 168.56 ( 9.6 ) 171.15 ( 9.82 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 83.75 ( 17.5 ) 85.82 ( 19.63 ) -
    BMI
    BMI - Body mass index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 29.41 ( 5.32 ) 29.28 ( 6.25 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Gaviscon® Double Action Liquid
    Reporting group description
    		 Gaviscon® Double Action 20 ml (2 x 10 ml) liquid sachets by mouth 4 times a day for 7 days

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo 20 ml (2 x 10 ml) liquid sachets by mouth 4 times a day for 7 days

    Primary: Number of subjects with Reduction of at least 3 days in HRDQ (heartburn & regurgitation) score >0.7 during 7-day treatment period compared to baseline (7-day run-in period)

    		 Close Top of page
    End point title
    		 Number of subjects with Reduction of at least 3 days in HRDQ (heartburn & regurgitation) score >0.7 during 7-day treatment period compared to baseline (7-day run-in period)
    End point description
    Intention-to-treat (ITT) population: All subjects in the safety set who were recruited into the study and had at least 1 day of complete HRDQ scores (severity and frequency scores for both Heartburn and Regurgitation) for both the run-in and treatment periods. Subjects were assigned to the treatment groups as randomised. This population was used for summaries of efficacy and baseline data. Heartburn Regurgitation and Dyspepsia Questionnaire (HRDQ): HRDQ symptom severity was recorded: 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
    Up to Day 7 (treatment period)
    End point values
    		 Gaviscon® Double Action Liquid Placebo
    Number of subjects analysed
    131
    131
    Units: Subjects
        Reduction in HRDQ Score >0.7: Less than 3 days
    64
    68
        Reduction in HRDQ Score >0.7: 3 days
    16
    24
        Reduction in HRDQ Score >0.7: 4 days
    13
    9
        Reduction in HRDQ Score >0.7: 5 days
    17
    13
        Reduction in HRDQ Score >0.7: 6 days
    12
    7
        Reduction in HRDQ Score >0.7: 7 days
    9
    10
        Reduction in HRDQ Score >0.7: 3 to 7 days
    67
    63
    Statistical analysis title
    		 Reduction in HRDQ Score >0.7: Gaviscon vs Placebo
    Comparison groups
    Placebo v Gaviscon® Double Action Liquid
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5939
    Method
    		 Regression, Logistic
    Confidence interval

    Secondary: Change in mean daily HRDQ score (heartburn and regurgitation) from baseline (7-day run-in period)

    		 Close Top of page
    End point title
    		 Change in mean daily HRDQ score (heartburn and regurgitation) from baseline (7-day run-in period)
    End point description
    ITT population.
    End point type
    Secondary
    End point timeframe
    Up to Day 7 (treatment period)
    End point values
    		 Gaviscon® Double Action Liquid Placebo
    Number of subjects analysed
    131
    131
    Units: unit on a scale
    arithmetic mean (standard deviation)
        Run-in Period
    1.79 ( 0.84 )
    1.64 ( 0.71 )
        Treatment Period
    0.91 ( 0.8 )
    0.84 ( 0.67 )
        Change from run-in to treatment periods
    -0.89 ( 0.8 )
    -0.8 ( 0.68 )
    Statistical analysis title
    		 HRDQ Score: Gaviscon vs Placebo
    Statistical analysis description
    HRDQ Score (Heartburn & Regurgitation)
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8435
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in mean daily heartburn and regurgitation score from baseline (7-day run-in period)

    		 Close Top of page
    End point title
    		 Change in mean daily heartburn and regurgitation score from baseline (7-day run-in period)
    End point description
    ITT population.
    End point type
    Secondary
    End point timeframe
    Up to Day 7 (treatment period)
    End point values
    		 Gaviscon® Double Action Liquid Placebo
    Number of subjects analysed
    131
    131
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Heartburn - Run-in Period
    0.94 ( 0.51 )
    0.85 ( 0.41 )
        Heartburn - Treatment Period
    0.45 ( 0.45 )
    0.41 ( 0.34 )
        Heartburn - Change from run-in to treatment period
    -0.49 ( 0.45 )
    -0.43 ( 0.39 )
        Regurgitation - Run-in period
    0.85 ( 0.47 )
    0.79 ( 0.43 )
        Regurgitation - Treatment period
    0.46 ( 0.43 )
    0.43 ( 0.4 )
        Regurgitation-Change b/w run-in & treatment period
    -0.4 ( 0.42 )
    -0.36 ( 0.36 )
    Statistical analysis title
    		 HRDQ Heartburn - Gaviscon vs Placebo
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8537
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 HRDQ Regurgitation - Gaviscon vs Placebo
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8409
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in mean daily frequency of individual symptoms (heartburn & regurgitation) from baseline (7-day run-in period)

    		 Close Top of page
    End point title
    		 Change in mean daily frequency of individual symptoms (heartburn & regurgitation) from baseline (7-day run-in period)
    End point description
    ITT population.
    End point type
    Secondary
    End point timeframe
    Up to Day 7 (treatment period)
    End point values
    		 Gaviscon® Double Action Liquid Placebo
    Number of subjects analysed
    131
    131
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Heartburn Frequency - Run-in Period
    3.98 ( 2.5 )
    3.46 ( 1.89 )
        Heartburn Frequency - Treatment Period
    1.97 ( 2.02 )
    1.81 ( 1.56 )
        Heartburn Frequency - Change from baseline
    -2.01 ( 1.97 )
    -1.65 ( 1.62 )
        Regurgitation Frequency - Run-in period
    3.82 ( 2.53 )
    3.44 ( 2.18 )
        Regurgitation Frequency - Treatment period
    2.26 ( 2.36 )
    2.02 ( 2.08 )
        Regurgitation Frequency -Change from baseline
    -1.56 ( 1.89 )
    -1.42 ( 1.44 )
    Statistical analysis title
    		 HRDQ Heartburn Frequency - Gaviscon vs Placebo
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5847
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 HRDQ Regurgitation Frequency - Gaviscon vs Placebo
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8618
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in mean daily severity of individual symptoms (heartburn & regurgitation) from baseline (7-day run-in period)

    		 Close Top of page
    End point title
    		 Change in mean daily severity of individual symptoms (heartburn & regurgitation) from baseline (7-day run-in period)
    End point description
    ITT population.
    End point type
    Secondary
    End point timeframe
    Up to Day 7 (treatment period)
    End point values
    		 Gaviscon® Double Action Liquid Placebo
    Number of subjects analysed
    131
    131
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Heartburn Severity - Run-in Period
    1.65 ( 0.63 )
    1.56 ( 0.57 )
        Heartburn Severity - Treatment Period
    0.94 ( 0.68 )
    0.92 ( 0.56 )
        Heartburn Severity - Change from baseline
    -0.71 ( 0.68 )
    -0.64 ( 0.57 )
        Regurgitation Severity - Run-in period
    1.53 ( 0.6 )
    1.45 ( 0.58 )
        Regurgitation Severity - Treatment period
    0.92 ( 0.65 )
    0.88 ( 0.61 )
        Regurgitation Severity -Change from baseline
    -0.61 ( 0.64 )
    -0.57 ( 0.57 )
    Statistical analysis title
    		 HRDQ Heartburn Severity - Gaviscon vs Placebo
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7243
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 HRDQ Regurgitation Severity - Gaviscon vs Placebo
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.935
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in mean daily duration of symptoms (heartburn & regurgitation) from baseline (7-day run-in period)

    		 Close Top of page
    End point title
    		 Change in mean daily duration of symptoms (heartburn & regurgitation) from baseline (7-day run-in period)
    End point description
    ITT population.
    End point type
    Secondary
    End point timeframe
    Up to Day 7 (treatment period)
    End point values
    		 Gaviscon® Double Action Liquid Placebo
    Number of subjects analysed
    131
    131
    Units: minutes
    arithmetic mean (standard deviation)
        Run-in period
    253.08 ( 295.08 )
    203.37 ( 244.58 )
        Treatment period
    136.05 ( 209.04 )
    126.14 ( 190.68 )
        Change from run-in to treatment periods
    -117.022 ( 217.499 )
    -77.231 ( 166.587 )
    Statistical analysis title
    		 HRDQ Daily Symptoms Duration - Gaviscon vs Placebo
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3304
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline (7-day run-in period) in patient satisfaction scores at end of study

    		 Close Top of page
    End point title
    		 Change from baseline (7-day run-in period) in patient satisfaction scores at end of study
    End point description
    ITT population. Patient satisfaction with medication 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?’ The patient had to draw a perpendicular line on a 100 mm Visual Analogue Scale (VAS), with anchors at 0 = ‘Very Dissatisfied’ and 100 = ‘Very Satisfied.’
    End point type
    Secondary
    End point timeframe
    Up to Day 8 (End of Study visit)
    End point values
    		 Gaviscon® Double Action Liquid Placebo
    Number of subjects analysed
    131
    131
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Run-in period
    30.99 ( 21.86 )
    36.23 ( 20.82 )
        Treatment period
    61.22 ( 29.93 )
    63.96 ( 27.96 )
        Change from run-in to treatment periods
    30.2 ( 35.08 )
    27.84 ( 28.51 )
    Statistical analysis title
    		 Patient Satisfaction scores - Gaviscon vs Placebo
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9028
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in mean reflux disease questionnaire (RDQ) symptom scores for GORD dimension from baseline (7-day run-in period)

    		 Close Top of page
    End point title
    		 Change in mean reflux disease questionnaire (RDQ) symptom scores for GORD dimension from baseline (7-day run-in period)
    End point description
    ITT population. RDQ consists of 12 items that describe 3 dimensions for assessment of heartburn, dyspepsia, & regurgitation. Heartburn and regurgitation can be combined into a GORD dimension. Each dimension includes 4 items measuring the frequency and severity of following questions: • A burning feeling behind your breastbone (heartburn) • Pain behind your breastbone (heartburn) • An acid taste in your mouth (regurgitation) • Unpleasant movement of material upwards from the stomach (regurgitation) • A burning feeling in the center of the upper stomach (dyspepsia) • A pain in the center of the upper stomach (dyspepsia) Response options are scaled with scores 0, 1, 2, 3, 4, 5 for frequencies (Did not have, 1 day, 2 days, 3-4 days, 5-6 days, Daily), whereas for Severity a 6-grade Likert scale is used (0=Did not have, 1=Very mild, 2=Mild, 3=Moderate, 4=Moderately severe, & 5=Severe).
    End point type
    Secondary
    End point timeframe
    Up to Day 7 (treatment period)
    End point values
    		 Gaviscon® Double Action Liquid Placebo
    Number of subjects analysed
    131
    131
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Run-in period
    2.87 ( 1.05 )
    2.72 ( 0.99 )
        Treatment period
    1.71 ( 1.17 )
    1.62 ( 1.16 )
        Change from run-in to treatment periods
    -1.15 ( 1.14 )
    -1.1 ( 1.15 )
    Statistical analysis title
    		 RDQ Scores for GORD Dimension -Gaviscon vs Placebo
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8288
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in mean RDQ scores for Heartburn and Regurgitation from baseline (7-day run-in period)

    		 Close Top of page
    End point title
    		 Change in mean RDQ scores for Heartburn and Regurgitation from baseline (7-day run-in period)
    End point description
    ITT population.
    End point type
    Secondary
    End point timeframe
    Up to Day 7 (treatment period)
    End point values
    		 Gaviscon® Double Action Liquid Placebo
    Number of subjects analysed
    131
    131
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Heartburn - Run-in Period
    2.76 ( 1.36 )
    2.63 ( 1.3 )
        Heartburn - Treatment Period
    1.72 ( 1.39 )
    1.7 ( 1.39 )
        Heartburn - Change from baseline
    -1.03 ( 1.39 )
    -0.95 ( 1.32 )
        Regurgitation - Run-in period
    2.98 ( 1.31 )
    2.81 ( 1.26 )
        Regurgitation - Treatment period
    1.7 ( 1.38 )
    1.55 ( 1.37 )
        Regurgitation - Change from baseline
    -1.27 ( 1.37 )
    -1.26 ( 1.35 )
    Statistical analysis title
    		 RDQ Heartburn - Gaviscon vs Placebo
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8854
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 RDQ Regurgitation - Gaviscon vs Placebo
    Comparison groups
    Placebo v Gaviscon® Double Action Liquid
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6107
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in mean RDQ frequency scores for heartburn and regurgitation from baseline (7-day run-in period)

    		 Close Top of page
    End point title
    		 Change in mean RDQ frequency scores for heartburn and regurgitation from baseline (7-day run-in period)
    End point description
    ITT population.
    End point type
    Secondary
    End point timeframe
    Up to Day 7 (treatment period)
    End point values
    		 Gaviscon® Double Action Liquid Placebo
    Number of subjects analysed
    131
    131
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Heartburn frequency - Run-in Period
    2.93 ( 1.56 )
    2.82 ( 1.52 )
        Heartburn frequency - Treatment Period
    1.83 ( 1.57 )
    1.87 ( 1.61 )
        Heartburn frequency - Change from baseline
    -1.09 ( 1.62 )
    -0.97 ( 1.56 )
        Regurgitation frequency - Run-in period
    3.13 ( 1.46 )
    2.97 ( 1.45 )
        Regurgitation frequency - Treatment period
    1.81 ( 1.54 )
    1.64 ( 1.55 )
        Regurgitation frequency - Change from baseline
    -1.31 ( 1.51 )
    -1.31 ( 1.58 )
    Statistical analysis title
    		 RDQ Heartburn frequency - Gaviscon vs Placebo
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7026
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 RDQ Regurgitation frequency - Gaviscon vs Placebo
    Comparison groups
    Placebo v Gaviscon® Double Action Liquid
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5541
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in mean RDQ severity scores for heartburn and regurgitation from baseline (7-day run-in period)

    		 Close Top of page
    End point title
    		 Change in mean RDQ severity scores for heartburn and regurgitation from baseline (7-day run-in period)
    End point description
    ITT population.
    End point type
    Secondary
    End point timeframe
    Up to Day 7 (treatment period)
    End point values
    		 Gaviscon® Double Action Liquid Placebo
    Number of subjects analysed
    131
    131
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Heartburn Severity - Run-in Period
    2.59 ( 1.29 )
    2.45 ( 1.2 )
        Heartburn Severity - Treatment Period
    1.61 ( 1.33 )
    1.53 ( 1.28 )
        Heartburn Severity - Change from baseline
    -0.98 ( 1.33 )
    -0.93 ( 1.24 )
        Regurgitation Severity - Run-in period
    2.82 ( 1.29 )
    2.66 ( 1.24 )
        Regurgitation Severity - Treatment period
    1.58 ( 1.33 )
    1.45 ( 1.29 )
        Regurgitation Severity -Change from baseline
    -1.24 ( 1.4 )
    -1.21 ( 1.28 )
    Statistical analysis title
    		 RDQ Heartburn Severity - Gaviscon vs Placebo
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8724
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 RDQ Regurgitation Severity - Gaviscon vs Placebo
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6732
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in mean HRDQ scores for number of nights with symptoms from baseline (7-day run-in period)

    		 Close Top of page
    End point title
    		 Change in mean HRDQ scores for number of nights with symptoms from baseline (7-day run-in period)
    End point description
    ITT population.
    End point type
    Secondary
    End point timeframe
    Up to Day 7 (treatment period)
    End point values
    		 Gaviscon® Double Action Liquid Placebo
    Number of subjects analysed
    131
    131
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Run-in period
    4.07 ( 2.67 )
    4.25 ( 2.52 )
        Treatment period
    2.57 ( 2.67 )
    2.69 ( 2.61 )
        Change from run-in to treatment periods
    -1.49 ( 2.48 )
    -1.56 ( 2.42 )
    Statistical analysis title
    		 HRDQ Night symptoms - Gaviscon vs Placebo
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Poisson regression model
    Confidence interval

    Secondary: Number of subjects with night-time symptoms

    		 Close Top of page
    End point title
    		 Number of subjects with night-time symptoms
    End point description
    ITT population.
    End point type
    Secondary
    End point timeframe
    At baseline (7-day run-in period) and Day 7 (treatment period)
    End point values
    		 Gaviscon® Double Action Liquid Placebo
    Number of subjects analysed
    131
    131
    Units: Subjects
        Run-in period - Yes
    107
    115
        Run-in period - No
    24
    16
        Treatment period - Yes
    83
    89
        Treatment period - No
    48
    42
    Statistical analysis title
    		 HRDQ subjects count with Night symptoms
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4158
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Days free from Heartburn and Regurgitation symptoms

    		 Close Top of page
    End point title
    		 Days free from Heartburn and Regurgitation symptoms
    End point description
    ITT population. Symptom-free day is defined as a day where the respective symptoms (heartburn and regurgitation — all derived from the HRDQ) had a value for frequency of 0.
    End point type
    Secondary
    End point timeframe
    Up to Day 7 (treatment period)
    End point values
    		 Gaviscon® Double Action Liquid Placebo
    Number of subjects analysed
    131
    131
    Units: Days
    arithmetic mean (standard deviation)
        Run-in period
    0.1 ( 0.49 )
    0.19 ( 0.5 )
        Treatment period
    1.45 ( 2.15 )
    1.45 ( 2.04 )
        Change from run-in to treatment periods
    1.35 ( 2.1 )
    1.26 ( 2 )
    Statistical analysis title
    		 HRDQ Symptom free days - Gaviscon vs Placebo
    Comparison groups
    Gaviscon® Double Action Liquid v Placebo
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Poisson regression model
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 8 (visit 3, End of Study)
    Adverse event reporting additional description
    Treatment-Emergent Adverse Events (TEAEs) for SAF population. Safety (SAF) population includes all subjects who were recruited into the study and received at least one dose of the study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Serious adverse events
    		 Overall study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 263 (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 study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    108 / 263 (41.06%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    2 / 263 (0.76%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    4 / 263 (1.52%)
         occurrences all number
    4
    Throat irritation
         subjects affected / exposed
    3 / 263 (1.14%)
         occurrences all number
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    4 / 263 (1.52%)
         occurrences all number
    4
    Epicondylitis
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Laceration
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Overdose
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    20 / 263 (7.60%)
         occurrences all number
    20
    Lethargy
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 263 (0.76%)
         occurrences all number
    2
    Eye disorders
    Visual impairment
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    3 / 263 (1.14%)
         occurrences all number
    3
    Abdominal distension
         subjects affected / exposed
    3 / 263 (1.14%)
         occurrences all number
    3
    Abdominal pain
         subjects affected / exposed
    4 / 263 (1.52%)
         occurrences all number
    4
    Abdominal pain upper
         subjects affected / exposed
    8 / 263 (3.04%)
         occurrences all number
    8
    Defaecation urgency
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    10 / 263 (3.80%)
         occurrences all number
    10
    Dyspepsia
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Flatulence
         subjects affected / exposed
    6 / 263 (2.28%)
         occurrences all number
    6
    Nausea
         subjects affected / exposed
    11 / 263 (4.18%)
         occurrences all number
    11
    Regurgitation
         subjects affected / exposed
    2 / 263 (0.76%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 263 (0.76%)
         occurrences all number
    2
    Back pain
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Osteoarthritis
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    2 / 263 (0.76%)
         occurrences all number
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    3 / 263 (1.14%)
         occurrences all number
    3
    Sinusitis
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 263 (0.38%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jul 2015
    The following changes to the study protocol were made: 1. The creation of additional subsections to accommodate the addition of an exploratory endpoint section. 2. The clarification of an existing secondary endpoint. 3. The reclassification of some secondary endpoints into exploratory endpoints. 4. The addition of a new endpoint to newly created exploratory endpoints section. 5. Changes to the compliance, calculations and which data to be used. 6. Correction to text for classification of AEs. 7. Administrative correction to Table 11-1. This amendment was considered to be substantial due to the impact on the scientific integrity of the study that the following changes had: The secondary endpoint was amended to specify the symptoms from which patients had to experience alleviation within the 7-day treatment period. The addition of a new secondary endpoint which specified the symptoms from which patients had to experience alleviation within the 7-day treatment period. Changes made had no impact on the conduct of the study. These were purely in relation to the analysis of data and/or correction to text.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28464343
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed Apr 24 20:55:41 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA