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    Clinical Trial Results:
    A double-blind, randomised, placebo-controlled study on the Efficacy of Iberogast® (STW 5) in patients with functional dyspepsia and concomitant reflux symptoms measured with impedance and wireless pH monitoring

    Summary
    EudraCT number
    		 2008-002305-40
    Trial protocol
    		 DE  
    Global end of trial date
    03 May 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Aug 2019
    First version publication date
    31 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY98-7411/20985
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser Wilhelm Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.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
    03 May 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To show the superiority of STW 5 compared to placebo for the treatment of patients with functional dyspepsia with concomitant reflux symptoms
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jun 2009
    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
    Germany: 63
    Worldwide total number of subjects
    63
    EEA total number of subjects
    63
    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)
    43
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In eight active centres in Germany, a total of 67 patients were screened for the study. Overall, 64 from the screened population were randomized, and 63 patients received treatment.

    Pre-assignment
    Screening details
    		 67 subjects were screened for the study. Overall, three patients from the screened population were not randomized, two of these did not meet the inclusion criteria, one patient discontinued prematurely due to ‘other reason’ (no pain).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 STW5
    Arm description
    		 Subjects will take STW5 orally from day 0 to day 28. The dosage was 20 drops three times daily before the meals.
    Arm type
    		 Experimental

    Investigational medicinal product name
    STW-5
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops, solution
    Routes of administration
    Oral use
    Dosage and administration details
    The medication was applied daily per os (orally, p.o.) from day 0 to day 28. The dosage was 20 drops three times daily before the meals.

    Arm title
    		 Placebo
    Arm description
    		 Subjects will take Placebo orally from day 0 to day 28. The dosage was 20 drops three times daily before the meals.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops, solution
    Routes of administration
    Oral use
    Dosage and administration details
    The medication was applied daily per os (orally, p.o.) from day 0 to day 28. The dosage was 20 drops three times daily before the meals.

    Number of subjects in period 1
    		STW5 Placebo
    Started
    33
    30
    Completed
    33
    29
    Not completed
    0
    1
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    STW5
    Reporting group description
    		 Subjects will take STW5 orally from day 0 to day 28. The dosage was 20 drops three times daily before the meals.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects will take Placebo orally from day 0 to day 28. The dosage was 20 drops three times daily before the meals.

    Reporting group values
    		 STW5 Placebo Total
    Number of subjects
    		 33 30 63
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 57.55 ( 16.266 ) 51.83 ( 13.414 ) -
    Gender categorical
    Units: Subjects
        Female
    		 28 23 51
        Male
    		 5 7 12

    End points

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    End points reporting groups
    Reporting group title
    STW5
    Reporting group description
    		 Subjects will take STW5 orally from day 0 to day 28. The dosage was 20 drops three times daily before the meals.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects will take Placebo orally from day 0 to day 28. The dosage was 20 drops three times daily before the meals.

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomised patients who received at least one dose of study medication. The set included all patients exposed to study treatment.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomised patients who received at least one dose of study medication and for whom post-randomisation data of efficacy is available. This set included patients with treatment effects measured, according to the intention-to-treat principle.

    Subject analysis set title
    Per-protocol set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol set included all patients from the full analysis set who essentially completed the study in compliance with the protocol and who reported no major violation of the study protocol. This might include but is not limited to meeting all inclusion criteria and not meeting any exclusion criteria, compliance with study treatment, and presenting with the required assessments of the primary target variable. The per-protocol set was the set of patients that participated in the trial as intended, according to the per-protocol principle.

    Primary: AUC of patients assessment of gastrointestinal symptoms

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    End point title
    		 AUC of patients assessment of gastrointestinal symptoms
    End point description
    Area under the curve (AUC) of patients` assessment of gastrointestinal symptoms evaluated by daily visual analogue scale (VAS)
    End point type
    Primary
    End point timeframe
    Up to 28 days
    End point values
    		 STW5 Placebo
    Number of subjects analysed
    31 [1]
    27 [2]
    Units: mm*days
        arithmetic mean (standard deviation)
    88.3 ( 8.75 )
    85.9 ( 9.29 )
    Notes
    [1] - 2 patients did not have post-treatment efficacy variable
    [2] - 3 patients did not have post-treatment efficacy variable
    Statistical analysis title
    		 Superiority of STW 5 against placebo
    Comparison groups
    STW5 v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8408
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Global Improvement Scale

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    End point title
    		 Global Improvement Scale
    End point description
    Assessed by Global Improvement Scale (substantially worsened/moderately worsened/ marginally worsened/not changed/ marginally improved/ moderately improved/ substantially improved).
    End point type
    Secondary
    End point timeframe
    At day 28
    End point values
    		 STW5 Placebo
    Number of subjects analysed
    31
    27
    Units: Subjects
    number (not applicable)
        My complaints have substantially improved
    8
    9
        My complaints have moderately improved
    7
    5
        My complaints have marginally improved
    3
    3
        My complaints have not changed
    8
    4
        My complaints have marginally worsened
    0
    0
        My complaints have moderately worsened
    1
    2
        My complaints have substantially worsened
    1
    1
        Not available
    3
    3
    No statistical analyses for this end point

    Secondary: Change of the Gastrointestinal Symptoms Profile (GIS) from baseline (visit 3) at the day 28 (visit 5)

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    End point title
    		 Change of the Gastrointestinal Symptoms Profile (GIS) from baseline (visit 3) at the day 28 (visit 5)
    End point description
    The GIS is a symptom related score, validated in German language, which allows the investigator to assess the dyspeptic symptoms by asking the patient for the following 10 items (GIS): epigastric pain / upper abdominal pain, abdominal cramps, fullness, early satiety, loss of appetite, sickness, nausea, vomiting, retrosternal discomfort and acid eructation/heartburn. The total GIS score is 40 points and an increasing summary score therefore represents a higher intensity of dyspeptic symptoms
    End point type
    Secondary
    End point timeframe
    At day 0 and day 28
    End point values
    		 STW5 Placebo
    Number of subjects analysed
    31
    27
    Units: Score
    arithmetic mean (standard deviation)
        Visit 3 (baseline)
    12.9 ( 4.41 )
    12.4 ( 3.69 )
        Visit 5
    7.7 ( 5.00 )
    6.4 ( 5.63 )
        Change from visit 5 to visit 3
    -5.1 ( 3.75 )
    -6.0 ( 4.81 )
    No statistical analyses for this end point

    Secondary: AUC of reflux symptoms assessment measured by daily VAS scale

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    End point title
    		 AUC of reflux symptoms assessment measured by daily VAS scale
    End point description
    Area under the curve (AUC) of assessment of reflux symptoms evaluated by daily visual analogue scale (VAS). VAS is an s an unmarked scale on a line 100 mm in length, indicating from 0 mm (no symptoms) to 100 mm (severe symptoms)
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    		 STW5 Placebo
    Number of subjects analysed
    31
    27
    Units: mm*days
    arithmetic mean (standard deviation)
        AUC of heartburn
    51.40 ( 47.151 )
    49.63 ( 42.813 )
        AUC of acid eructation
    46.53 ( 47.905 )
    42.27 ( 36.350 )
    No statistical analyses for this end point

    Secondary: FDDQL total score and change from baseline at visit 5

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    End point title
    		 FDDQL total score and change from baseline at visit 5
    End point description
    The Functional Dyspepsia Quality of Life (FDDQL) provided a profile with eight subscores (daily activities, anxiety, diet, sleep, discomfort, health perceptions, coping with disease and impact of stress) as well as a global score. Sub-scale scores and the global score were transformed to a range from "0 = Poor QoL" to "100= Good QoL".
    End point type
    Secondary
    End point timeframe
    At baseline and day 28 (visit 5)
    End point values
    		 STW5 Placebo
    Number of subjects analysed
    31
    27
    Units: Score
    arithmetic mean (standard deviation)
        Visit 3 (baseline)
    42.5 ( 15.05 )
    45.3 ( 13.22 )
        Visit 5
    34.9 ( 15.97 )
    34.1 ( 14.21 )
        Change from visit 5 to baseline
    -7.5 ( 10.67 )
    -11.2 ( 15.58 )
    No statistical analyses for this end point

    Secondary: Esophageal ph measurement using the BravoTM pH system and intraluminal impedance

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    End point title
    		 Esophageal ph measurement using the BravoTM pH system and intraluminal impedance
    End point description
    End point type
    Secondary
    End point timeframe
    BravoTM pH system: at day -7/ -5 (screening phase) and day 29/30 if applicable Intraluminal impedance: at day -1 (screening phase) and day 29/30 if applicable
    End point values
    		 STW5 Placebo
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: ph
        number (not applicable)
    Notes
    [3] - Due to few data available, no summary statistics or results of an ANCOVA can be presented
    [4] - Due to few data available, no summary statistics or results of an ANCOVA can be presented.
    No statistical analyses for this end point

    Secondary: Global assessment of efficacy judged by patient using a five point Likert scale

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    End point title
    		 Global assessment of efficacy judged by patient using a five point Likert scale
    End point description
    1 = very good, 2 = good, 3 = moderate, 4 = poor, 5 = very poor
    End point type
    Secondary
    End point timeframe
    At day 28
    End point values
    		 STW5 Placebo
    Number of subjects analysed
    31
    27
    Units: Subjects
        Very good
    7
    9
        Good
    9
    6
        Moderate
    6
    3
        Poor
    6
    7
        Very poor
    3
    2
    No statistical analyses for this end point

    Secondary: Global assessment of efficacy judged by physician using a five point Likert scale

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    End point title
    		 Global assessment of efficacy judged by physician using a five point Likert scale
    End point description
    1 = very good, 2 = good, 3 = moderate, 4 = poor, 5 = very poor
    End point type
    Secondary
    End point timeframe
    At day 28
    End point values
    		 STW5 Placebo
    Number of subjects analysed
    31
    27
    Units: Subjects
        Very good
    7
    8
        Good
    12
    6
        Moderate
    4
    3
        Poor
    6
    9
        Very poor
    2
    1
    No statistical analyses for this end point

    Secondary: Change of Individual symptom score from baseline (visit 3) at day 28 (visit 5)

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    End point title
    		 Change of Individual symptom score from baseline (visit 3) at day 28 (visit 5)
    End point description
    The GIS sub-scores for epigastric pain (item 1) and reflux symptoms (item 10). The sub-scores were assessed and analysed using the following scores: 0 = No problem, 1 = Mild problem, 2 = Moderate problem, 3 = Severe problem, 4 = Very severe
    End point type
    Secondary
    End point timeframe
    At baseline and day 28
    End point values
    		 STW5 Placebo
    Number of subjects analysed
    31
    27
    Units: Score
    arithmetic mean (standard deviation)
        Epigatric pain: visit 3 (baseline)
    2.2 ( 0.72 )
    2.2 ( 0.75 )
        Epigatric pain: visit 5
    1.4 ( 0.88 )
    1.0 ( 0.98 )
        Epigatric pain: change from visit 5 to visit 3
    -0.9 ( 0.85 )
    -1.2 ( 0.92 )
        Reflux system: visit 3 (baseline)
    1.7 ( 0.74 )
    2.0 ( 0.78 )
        Reflux system: visit 5
    1.1 ( 0.68 )
    0.9 ( 0.89 )
        Reflux system: change from visit 5 to visit 3
    -0.6 ( 0.66 )
    -1.1 ( 1.25 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From day 0 to day 28 (end of study)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    STW5
    Reporting group description
    		 Subjects will take STW5 orally from day 0 to day 28. The dosage was 20 drops three times daily before the meals.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects will take Placebo orally from day 0 to day 28. The dosage was 20 drops three times daily before the meals.

    Serious adverse events
    		 STW5 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 30 (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
    		 STW5 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 33 (15.15%)
    7 / 30 (23.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Intercostal neuralgia
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Nerve compression
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Dyspepsia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    0
    3
    Vomiting
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 30 (3.33%)
         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
    20 Jan 2009
    The address of principle investigator changed
    22 Jan 2010
    The BRAVO procedure was changed to voluntarily

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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