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    Clinical Trial Results:
    Efficacy and Tolerability of Menthacarin in Patients (>= 18 years old) suffering from symptoms of Irritable Bowel Syndrome (IBS)

    Summary
    EudraCT number
    		 2014-004702-14
    Trial protocol
    		 DE  
    Global end of trial date
    15 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jun 2020
    First version publication date
    14 Jun 2020
    Other versions
    Summary report(s)
    		 530079.01.302 Summary of results 2020_05_29

    Trial information

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    Trial identification
    Sponsor protocol code
    530079.01.302
    Additional study identifiers
    ISRCTN number
    		 ISRCTN31630783
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. Willmar-Schwabe GmbH & Co. KG
    Sponsor organisation address
    Willmar-Schwabe-Str. 4, Karlsruhe, Germany, 76227
    Public contact
    Head of Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, 49 7214005573,
    Scientific contact
    Head of Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, 49 7214005573,
    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
    16 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy and tolerability of Menthacarin® in patients (>= 18 years old) suffering from symptoms of IBS.
    Protection of trial subjects
    Possibility to withdraw informed consent. Monitoring of adverse events and laboratory parameters.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Jul 2016
    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: 226
    Worldwide total number of subjects
    226
    EEA total number of subjects
    226
    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)
    205
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Twenty-two trial centres in Germany participated in the trial.

    Pre-assignment
    Screening details
    		 A total of 226 patients were screened for enrollment into the trial. Four patients were re-screened and received a new patient number. Therefore, 230 patient numbers exist. Twenty-six of the 226 screened patients were not randomized and did not receive trial medication. One patient was randomized but did not take study medication.

    Pre-assignment period milestones
    Number of subjects started
    		 226
    Number of subjects completed
    		 199

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screening Failures: 20
    Reason: Number of subjects
    		 Consent withdrawn by subject: 5
    Reason: Number of subjects
    		 Scheduling Issues: 2
    Period 1
    Period 1 title
    Treatment period 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    Double blind

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menthacarin
    Arm description
    		 Menthacarin (Mentha x piperita L. (90 mg WS® 1340) and Carum carvi (50 mg WS® 1520)), 1 soft capsule taken 2 times daily (1-1-0)
    Arm type
    		 Experimental

    Investigational medicinal product name
    WS® 1340 / WS® 1520
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    1-1-0

    Arm title
    		 Placebo
    Arm description
    		 Placebo, 1 soft capsule taken 2 times daily (1-1-0)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    1-1-0

    Number of subjects in period 1 [1]
    		Menthacarin Placebo
    Started
    100
    99
    Completed
    93
    94
    Not completed
    7
    5
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    3
    1
         Other reason
    -
    1
         Lost to follow-up
    1
    -
         Lack of efficacy
    1
    2
    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: In total, 27 of the 226 subjects screened for inclusion into the study were not included into the baseline period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Menthacarin
    Reporting group description
    		 Menthacarin (Mentha x piperita L. (90 mg WS® 1340) and Carum carvi (50 mg WS® 1520)), 1 soft capsule taken 2 times daily (1-1-0)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, 1 soft capsule taken 2 times daily (1-1-0)

    Reporting group values
    		 Menthacarin Placebo Total
    Number of subjects
    		 100 99 199
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 89 91 180
        From 65-84 years
    		 11 8 19
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.9 ( 15.8 ) 39.7 ( 14.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 80 76 156
        Male
    		 20 23 43
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS included all patients of the Safety analysis set who had at least one measure of the primary efficacy parameter (pain score for 7 days to allow the calculation of a weekly average) during the active treatment period after baseline visit and patients who terminated the trial prematurely because of lack of efficacy or unexpected improvement/remission of disease (after at least 14 days of treatment) or an AE for which a causal relationship to trial medication was not excluded (even if the patient had no efficacy measurement during active treatment period).

    Subject analysis sets values
    		 Full Analysis Set
    Number of subjects
    196
    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)
    177
        From 65-84 years
    19
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    41.0 ( 15.1 )
    Gender categorical
    Units: Subjects
        Female
    153
        Male
    43

    End points

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    End points reporting groups
    Reporting group title
    Menthacarin
    Reporting group description
    		 Menthacarin (Mentha x piperita L. (90 mg WS® 1340) and Carum carvi (50 mg WS® 1520)), 1 soft capsule taken 2 times daily (1-1-0)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, 1 soft capsule taken 2 times daily (1-1-0)

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS included all patients of the Safety analysis set who had at least one measure of the primary efficacy parameter (pain score for 7 days to allow the calculation of a weekly average) during the active treatment period after baseline visit and patients who terminated the trial prematurely because of lack of efficacy or unexpected improvement/remission of disease (after at least 14 days of treatment) or an AE for which a causal relationship to trial medication was not excluded (even if the patient had no efficacy measurement during active treatment period).

    Primary: Change in abdominal pain (using an 11 point numeric rating scale (NRS))

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    End point title
    		 Change in abdominal pain (using an 11 point numeric rating scale (NRS)) [1]
    End point description
    Note: This document in its section "End points" specifies commercially confidential information of Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe referred to in Article 81 Section (4) b) Regulation (EU) 536/2014 that is a trade secret and released by the holder for purposes of Regulation (EU) 536/2014 only under the conditon of confidence. Trade secrets may not - even in part - be published or released to third parties other than to competent authorities without express permission of the trade secret holder.
    End point type
    Primary
    End point timeframe
    Day 0 and Day 28
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The reported results are chosen freely. See document for a complete description of the statistical methods and results. Statistical analyses were conducted for the end point. Refer to the attached summary of results for details.
    End point values
    		 Menthacarin Placebo
    Number of subjects analysed
    100
    99
    Units: points
        median (confidence interval 95%)
    9999.99 (9999.99 to 9999.99)
    9999.99 (9999.99 to 9999.99)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks
    Adverse event reporting additional description
    Efficacy and tolerability of Carmenhtin in patients suffering from irritable bowel syndrome
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    No active treatment
    Reporting group description
    		 No active treatment

    Reporting group title
    Menthacarin
    Reporting group description
    		 Study medication

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 No active treatment Menthacarin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 194 (0.52%)
    1 / 139 (0.72%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 194 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 194 (0.52%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 No active treatment Menthacarin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 200 (1.50%)
    8 / 194 (4.12%)
    9 / 139 (6.47%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 200 (1.50%)
    8 / 194 (4.12%)
    9 / 139 (6.47%)
         occurrences all number
    3
    8
    9

    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.
    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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