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    Clinical Trial Results:
    Functional Dyspepsia: validation of a questionnaire for symptom assessment in patients suffering from Postprandial Distress Syndrome (Functional Dyspepsia): assessment of sensitivity to change in PDS symptom severity in an interventional study

    Summary
    EudraCT number
    2012-004296-39
    Trial protocol
    BE  
    Global end of trial date
    08 Jan 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    18 Apr 2021
    First version publication date
    18 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LPDSItopride
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UZLeuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Jan Tack, UZLeuven, 32 16344225, jan.tack@uzleuven.be
    Scientific contact
    Florencia Carbone, UZLeuven, 32 16330816, florencia.carbone@kuleuven.be
    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
    29 Nov 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To validate a PRO in line with the FDA guideline, according to early EMA input and with close adherence with DSSI instrument that showed responsiveness in a US phase II.
    Protection of trial subjects
    not applicable
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Sep 2013
    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
    Belgium: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Consecutive out-patients diagnosed with postprandial distress syndrome according to Rome III criteria at eleven gastroenterology practices in Belgium were eligible for the study. Both French and Dutch speaking patients between the ages of 18 and 70 years were included.

    Pre-assignment
    Screening details
    patients were included if they were confirmed to suffer from active postprandial distress syndrome as per LPDS scoring system during the 2 weeks eligibility period. This required the presence of at least moderate (score 2) postprandial fullness and/or early satiation symptoms on at least 4 days during the 2 weeks eligibility period.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    itopride
    Arm description
    Itopride (100 mg three times daily)
    Arm type
    Active comparator

    Investigational medicinal product name
    itopride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Itopride 100 mg, three times daily

    Arm title
    placebo
    Arm description
    placebo three times daily
    Arm type
    Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    placebo tablet, three times daily

    Number of subjects in period 1
    itopride placebo
    Started
    60
    60
    Completed
    60
    60

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    treatment period
    Reporting group description
    -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Statistical analysis was performed after inclusion of the first 60 patients.
    Reporting group values
    treatment period Total
    Number of subjects
    60 60
    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
    patients between the ages of 18 and 70 years
    Units: years
        arithmetic mean (standard deviation)
    38.2 ± 2.1 -
    Gender categorical
    Units: Subjects
        Female
    50 50
        Male
    10 10

    End points

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    End points reporting groups
    Reporting group title
    itopride
    Reporting group description
    Itopride (100 mg three times daily)

    Reporting group title
    placebo
    Reporting group description
    placebo three times daily

    Primary: Validation of the Leuven Postprandial Distress Scale

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    End point title
    Validation of the Leuven Postprandial Distress Scale
    End point description
    The LPDS diary, comprising eight symptoms with verbal descriptors rated for severity (0–4), was derived from focus groups and cognitive debriefing. It was used in a 2-week run-in, 8-week double-blind placebo-controlled trial of itopride 100 mg t.d.s. Results in 60 patients, with concealed treatment allocation, were used to analyse LPDS content validity, consistency, reliability and responsiveness. Patients also filled out Patient Assessment of Gastrointestinal Symptoms (PAGI-SYM), Nepean Dyspepsia Index, overall treatment evaluation and overall symptom severity questionnaires. Construct validity was evaluated by known-group analyses and by correlating LPDS with these additional questionnaires. Minimum Clinically Important Difference was determined from threshold changes in anchor questionnaires.
    End point type
    Primary
    End point timeframe
    The end of treatment measurements (visit 6 of the trial) were used for responsiveness.
    End point values
    itopride placebo
    Number of subjects analysed
    60 [1]
    60 [2]
    Units: severity scale
        arithmetic mean (standard deviation)
    0.58 ± 0.11
    0.58 ± 0.11
    Notes
    [1] - the code was not broken for the analysis of this study aim. Analysis was performed on total of 60 pt
    [2] - the code was not broken for the analysis of this study aim. Analysis was performed on total of 60 pt
    Statistical analysis title
    MINIMUM CLINICALLY IMPORTANT DIFFERENCE
    Statistical analysis description
    The minimum clinically important difference was determined for each anchor at both visits 4 and 6 by regressing the change between visit 2 and visit 4 or 6 in the postprandial distress syndrome domain of the LPDS (dependent variable) on the corresponding change in an anchor variable (independent variable).
    Comparison groups
    placebo v itopride
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    = 0 [4]
    Method
    Regression, Linear
    Confidence interval
    Notes
    [3] - The slope of this regression model defines the minimum clinically important difference, since it estimates how much the postprandial distress syndrome changes within patients, on average, per unit (one point) change in the external measure. Scatterplots of dependent and independent variables were examined to check that there is no clear departure from the assumption of linearity.
    [4] - P value is not applicable. The study aim was the validation of a questionnaire. The code was not broken for this analysis. Statistical nalysis is performed on total of 60 subjects.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    For each individual, corresponds to timeframe of study participation (from signing of informed consent until last visit).
    Adverse event reporting additional description
    The most common possible adverse reactions to the study drug (itopride or placebo, as the code was not broken) were headache (13%), insomnia (5%) and dizziness (3%).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23
    Frequency threshold for reporting non-serious adverse events: 5%
    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: The most common possible adverse reactions to the study drug (itopride or placebo, as the code was not broken) were headache (13%), insomnia (5%) and dizziness (3%).

    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.
    This trial was set up to investigate if The Leuven Postprandial Distress Scale (LPDS) is a sensitive and reliable patient-reported outcome instrument to assess symptoms in the functional dyspepsia/postprandial distress syndrome.

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/27518319
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