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    Clinical Trial Results:
    MULTICENTRIC RANDOMIZED PLACEBO-CONTROLLED DOUBLE-BLIND 2-ARM PIVOTAL STUDY ON EFFICACY AND SAFETY OF ARHAMA®-TINKTUR N IN PATIENS WITH ACUTE DIARRHEA

    Summary
    EudraCT number
    2011-001776-19
    Trial protocol
    DE  
    Global end of trial date
    29 Apr 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    25 Nov 2021
    First version publication date
    25 Nov 2021
    Other versions
    Summary report(s)
    ISR2014

    Trial information

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    Trial identification
    Sponsor protocol code
    2010-19
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    CardioSec Clinical Research GmbH
    Sponsor organisation address
    Dalbergsweg 21, Erfurt, Germany, D-99084
    Public contact
    Project manager, CardioSec Clinical Research GmbH, 0049 36178919740, info@cardiosec.de
    Scientific contact
    Project manager, CardioSec Clinical Research GmbH, 0049 36178919740, info@cardiosec.de
    Sponsor organisation name
    Bombastus-Werke AG
    Sponsor organisation address
    Wilsdruffer Str. 170, Freital, Germany, D-01705
    Public contact
    Mathias Solf, Head of R&D, 0049 3516580354, m.solf@bombastus-werke.de
    Scientific contact
    Mathias Solf, Head of R&D, 0049 3516580354, m.solf@bombastus-werke.de
    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 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Superiority of oral treatment with Arhama®-Tinktur N (7,5 ml oral per 48 hours) compared to placebo
    Protection of trial subjects
    exclusion of severe cases
    Background therapy
    individual possible, was recorded
    Evidence for comparator
    Similar to Verum in colour and taste but without effect
    Actual start date of recruitment
    01 Sep 2011
    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: 470
    Worldwide total number of subjects
    470
    EEA total number of subjects
    470
    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)
    447
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    26 investigation partners in Germany were involved. They included patients according to the determined criteria.

    Pre-assignment
    Screening details
    checking diagnosis, Inclusion and exclusion criteria.

    Pre-assignment period milestones
    Number of subjects started
    472 [1]
    Intermediate milestone: Number of subjects
    pre assignment: 472
    Intermediate milestone: Number of subjects
    Randomisation: 472
    Number of subjects completed
    470

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Consent withdrawn by subject: 1
    Reason: Number of subjects
    Pregnancy: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 472-2=470, this are the real numbers before and after randomisation
    Period 1
    Period 1 title
    preparation (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    Verum- / Placebo- Solutions were filled in identical 100-ml- glass bottles. They were individualised with labels with the "randomisation number". The corresponding list of the numbers and relation to the study-arms was unknown to patients and investigators.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Verum
    Arm description
    Dosing of 7.5 ml Verum preparation at initialisation and than in Intervals of 48 h until end of diarrhea
    Arm type
    Experimental

    Investigational medicinal product name
    Arhama-Tinktur N
    Investigational medicinal product code
    Other name
    Verum preparation
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Dosing of 7.5 ml Verum preparation at initialisation and than in Intervals of 48 h until end of diarrhea

    Arm title
    Placebo
    Arm description
    Dosing of 7.5 ml Placebo preparation at initialisation and than in Intervals of 48 h until end of diarrhea
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo

    Number of subjects in period 1
    Verum Placebo
    Started
    234
    236
    Completed
    223
    231
    Not completed
    11
    5
         Adverse event, non-fatal
    3
    -
         Lost to follow-up
    6
    1
         Lack of efficacy
    2
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    preparation
    Reporting group description
    -

    Reporting group values
    preparation Total
    Number of subjects
    470 470
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    447 447
        From 65-84 years
    23 23
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    38.0 ( 14.3 ) -
    Gender categorical
    Units: Subjects
        Female
    248 248
        Male
    222 222
    Subject analysis sets

    Subject analysis set title
    PPS
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients without distinct protocol deviations

    Subject analysis set title
    FAS
    Subject analysis set type
    Full analysis
    Subject analysis set description
    all included patients

    Subject analysis sets values
    PPS FAS
    Number of subjects
    432
    470
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    412
    447
        From 65-84 years
    20
    23
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    38.1 ( 14.1 )
    38.0 ( 14.3 )
    Gender categorical
    Units: Subjects
        Female
    227
    248
        Male
    205
    222

    End points

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    End points reporting groups
    Reporting group title
    Verum
    Reporting group description
    Dosing of 7.5 ml Verum preparation at initialisation and than in Intervals of 48 h until end of diarrhea

    Reporting group title
    Placebo
    Reporting group description
    Dosing of 7.5 ml Placebo preparation at initialisation and than in Intervals of 48 h until end of diarrhea

    Subject analysis set title
    PPS
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients without distinct protocol deviations

    Subject analysis set title
    FAS
    Subject analysis set type
    Full analysis
    Subject analysis set description
    all included patients

    Primary: duration of diarrhoea

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    End point title
    duration of diarrhoea
    End point description
    End point type
    Primary
    End point timeframe
    15.11.2011 - 04.09.2013
    End point values
    Verum Placebo
    Number of subjects analysed
    234
    236
    Units: hours
        arithmetic mean (standard deviation)
    23.9 ( 11.8 )
    24.5 ( 11.9 )
    Statistical analysis title
    Duration of diarrhoea
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    470
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [1]
    P-value
    > 0.0038 [2]
    Method
    Kaplan-Meier-Analyse
    Confidence interval
    Notes
    [1] - zero-Hypothesis: The Duration of diarrhoea is equal in both study arms.
    [2] - p=0.067 => the zero-Hypothesis is true

    Post-hoc: Duration of diarrhoea (DD) for patients with DD>48h

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    End point title
    Duration of diarrhoea (DD) for patients with DD>48h
    End point description
    for patients with Duration of diarrhoea >48h revealed an benefit for Verum with statistical relevance
    End point type
    Post-hoc
    End point timeframe
    15.11.2011 - 04.09.2013
    End point values
    Verum Placebo
    Number of subjects analysed
    97
    94
    Units: hours
        median (confidence interval 5%)
    99.7 (68.3 to 131.1)
    113.5 (65.0 to 162.0)
    Attachments
    post-hoc-graph
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    15.11.2011 - 04.09.2013
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Verum
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    Verum Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 234 (0.43%)
    0 / 236 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    10044552, 10009900
         subjects affected / exposed
    1 / 234 (0.43%)
    0 / 236 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Verum Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 234 (8.55%)
    27 / 236 (11.44%)
    Investigations
    10048553 10008578 10018644 10026972
         subjects affected / exposed
    4 / 234 (1.71%)
    4 / 236 (1.69%)
         occurrences all number
    4
    4
    Nervous system disorders
    10013649 10019211
         subjects affected / exposed
    2 / 234 (0.85%)
    4 / 236 (1.69%)
         occurrences all number
    2
    4
    General disorders and administration site conditions
    10008531 10072005
         subjects affected / exposed
    1 / 234 (0.43%)
    1 / 236 (0.42%)
         occurrences all number
    1
    1
    Eye disorders
    10010741 10010694
         subjects affected / exposed
    2 / 234 (0.85%)
    1 / 236 (0.42%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    10038263 10000055 10017865 10028813
         subjects affected / exposed
    5 / 234 (2.14%)
    14 / 236 (5.93%)
         occurrences all number
    5
    14
    Musculoskeletal and connective tissue disorders
    10059671 10023477 10048412
         subjects affected / exposed
    2 / 234 (0.85%)
    1 / 236 (0.42%)
         occurrences all number
    2
    1
    Infections and infestations
    10046544 10033078 10047463 10061735
         subjects affected / exposed
    4 / 234 (1.71%)
    2 / 236 (0.85%)
         occurrences all number
    4
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Apr 2012
    -additional blood sample for the immune subset

    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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