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    Clinical Trial Results:
    The effect of on demand versus continuous use of proton pump inhibitors on reflux symptoms, quality of life and self-rated health in patients with gastro-oesophageal reflux disease

    Summary
    EudraCT number
    		 2014-001314-25
    Trial protocol
    		 NL  
    Global end of trial date
    09 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2023
    First version publication date
    10 Feb 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KIANANDR140701
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Karolinska Institutet
    Sponsor organisation address
    Alfred Nobels allé 12, Huddinge, Sweden,
    Public contact
    Centre for Family Medicine, Karolinska Institutet, 46 0852488000, villvetamer@cefam.se
    Scientific contact
    Anna Andreasson, Centre for Family Medicine, Karolinska Institutet, 46 0852488000, anna.andreasson@su.se
    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
    Interim
    Date of interim/final analysis
    09 Mar 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To evaluate whether there is a difference in symptom relief in patients prescribed PPI on demand and patients prescribed continuous use of PPI. 2. To evaluate whether the use of electronic tools developed to facilitate clinical trials in primary care result in a higher recruitment rates than paper-based data collection.
    Protection of trial subjects
    Trial subjects were primary care patients that received one of two approved treatments for gastroesophageal reflux disease. The trial subjects were asked to fill out a questionnaire about drug consumption and health related quality of life (QoL), that took approximately 20 minutes each, total 40 minutes. No specific measures were put in place to protect the trial subjects, as they recieved standard care and the questionnaire was brief and the content should not cause pain or distress.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 May 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 17
    Country: Number of subjects enrolled
    Greece: 248
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    Poland: 336
    Worldwide total number of subjects
    615
    EEA total number of subjects
    615
    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)
    615
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted between May and December 2015. 36 primary care centres participated in the study: 8 in Greece, 10 in Poland, 8 in the Netherlands and 10 in the UK.

    Pre-assignment
    Screening details
    		 Eligible patients were adults 18 to 65 years of age diagnosed with GERD and requiring PPI treatment i.e. symptoms at least 2 times a week negatively influencing quality of life that had previously been prescribed and obtained symptom relief from PPI use (PPI treatment responders).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 On demand
    Arm description
    		 This patient group was given on demand use of PPI (20 mg Omeprazole on demand, maximum daily intake two pills i.e. 40 mg).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Omeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg Omeprazole on demand, maximum daily intake two pills i.e. 40 mg

    Arm title
    		 Continous use
    Arm description
    		 This patient group was given continous prescription of PPI (20 mg Omeprazole daily).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Omeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg Omeprazole daily

    Number of subjects in period 1
    		On demand Continous use
    Started
    310
    305
    Completed
    228
    231
    Not completed
    82
    74
         Lost to follow-up
    82
    74

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    On demand
    Reporting group description
    		 This patient group was given on demand use of PPI (20 mg Omeprazole on demand, maximum daily intake two pills i.e. 40 mg).

    Reporting group title
    Continous use
    Reporting group description
    		 This patient group was given continous prescription of PPI (20 mg Omeprazole daily).

    Reporting group values
    		 On demand Continous use Total
    Number of subjects
    		 310 305 615
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 50 (41 to 59) 51 (41 to 59) -
    Gender categorical
    Units: Subjects
        Female
    		 177 181 358
        Male
    		 133 124 257
    PPI current user
    Units: Subjects
        Yes
    		 177 179 356
        No
    		 133 126 259

    End points

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    End points reporting groups
    Reporting group title
    On demand
    Reporting group description
    		 This patient group was given on demand use of PPI (20 mg Omeprazole on demand, maximum daily intake two pills i.e. 40 mg).

    Reporting group title
    Continous use
    Reporting group description
    		 This patient group was given continous prescription of PPI (20 mg Omeprazole daily).

    Primary: GERD symptom burden

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    End point title
    		 GERD symptom burden
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to follow up 8 weeks later
    End point values
    		 On demand Continous use
    Number of subjects analysed
    228
    231
    Units: score
        arithmetic mean (standard deviation)
    0.70 ( 0.75 )
    0.71 ( 0.76 )
    Statistical analysis title
    		 Difference in GERD symptom burden
    Statistical analysis description
    Difference in GERD symptom burden between on demand PPI users and continuous PPI users at follow-up visit
    Comparison groups
    Continous use v On demand
    Number of subjects included in analysis
    459
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.84
    Method
    		 Regression, Linear
    Confidence interval
    Notes
    [1] - Mixed effect regression model with interaction time treatment to test for treatment effect

    Primary: SF-12 physical health score

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    End point title
    		 SF-12 physical health score
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to follow up 8 weeks later
    End point values
    		 On demand Continous use
    Number of subjects analysed
    228
    231
    Units: score
        arithmetic mean (standard deviation)
    51.92 ( 7.75 )
    51.17 ( 8.73 )
    Statistical analysis title
    		 Difference in physical health QoL score
    Statistical analysis description
    Difference in physical health QoL score between on demand PPI users and continuous PPI users at follow-up visit
    Comparison groups
    On demand v Continous use
    Number of subjects included in analysis
    459
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 = 0.46
    Method
    		 Regression, Linear
    Confidence interval
    Notes
    [2] - Mixed effect regression model with interaction time treatment to test for treatment effect

    Primary: SF-12 mental health score

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    End point title
    		 SF-12 mental health score
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to follow up 8 weeks later
    End point values
    		 On demand Continous use
    Number of subjects analysed
    228
    231
    Units: score
        arithmetic mean (standard deviation)
    46.98 ( 8.15 )
    48.31 ( 7.20 )
    Statistical analysis title
    		 Difference in mental health QoL score
    Statistical analysis description
    Difference in mental health QoL score between on demand PPI users and continuous PPI users at follow-up visit
    Comparison groups
    On demand v Continous use
    Number of subjects included in analysis
    459
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 = 0.17
    Method
    		 Regression, Linear
    Confidence interval
    Notes
    [3] - Mixed effect regression model with interaction time treatment to test for treatment effect

    Primary: Self-rated health

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    End point title
    		 Self-rated health
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to follow up 8 weeks later
    End point values
    		 On demand Continous use
    Number of subjects analysed
    228
    231
    Units: score
        arithmetic mean (standard deviation)
    2.13 ( 0.80 )
    2.17 ( 0.88 )
    Statistical analysis title
    		 Difference in self-rated health
    Statistical analysis description
    Difference in self-rated health between on demand PPI users and continuous PPI users at follow-up visit
    Comparison groups
    On demand v Continous use
    Number of subjects included in analysis
    459
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    P-value
    		 = 0.61
    Method
    		 Regression, Linear
    Confidence interval
    Notes
    [4] - Mixed effect regression model with interaction time treatment to test for treatment effect

    Secondary: PPI use last week

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    End point title
    		 PPI use last week
    End point description
    End point type
    Secondary
    End point timeframe
    At follow up (8 weeks)
    End point values
    		 On demand Continous use
    Number of subjects analysed
    228
    231
    Units: dose
        arithmetic mean (standard deviation)
    12.10 ( 49.07 )
    16.45 ( 45.63 )
    Statistical analysis title
    		 Difference in PPI intake
    Statistical analysis description
    Difference in PPI intake at follow-up visit
    Comparison groups
    On demand v Continous use
    Number of subjects included in analysis
    459
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority [5]
    P-value
    		 = 0.33
    Method
    		 Regression, Linear
    Confidence interval
    Notes
    [5] - Mixed effect regression model with interaction time treatment to test for treatment effect

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    13/05/2015 – 31/12/2015
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Free text
    Dictionary version
    n/a
    Reporting groups
    Reporting group title
    On demand
    Reporting group description
    		 This patient group was given on demand use of PPI (20 mg Omeprazole on demand, maximum daily intake two pills i.e. 40 mg).

    Reporting group title
    Continous use
    Reporting group description
    		 This patient group was given continous prescription of PPI (20 mg Omeprazole daily).

    Serious adverse events
    		 On demand Continous use
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 310 (0.00%)
    0 / 305 (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
    		 On demand Continous use
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 310 (0.00%)
    0 / 305 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no non-serious adverse events recorded for these results.

    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.
    Limitations include missing data on symptoms and health related quality of life of the participants who used the TRANSFoRm tool to complete questionnaires, however, this was largely due to a technical issue and data loss can be assumed to be random.
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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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