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    Clinical Trial Results:
    Safety and tolerability of Pelargonium sidoides extract EPs® 7630 in children (1 to 5 years old) suffering from acute bronchitis

    Summary
    EudraCT number
    		 2011-002652-14
    Trial protocol
    		 DE  
    Global end of trial date
    15 Jul 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Sep 2018
    First version publication date
    30 Sep 2018
    Other versions
    Summary report(s)
    		 701003.01.010 Summary of results of postin in eudra Ct database V1.0 2018_09_14

    Trial information

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    Trial identification
    Sponsor protocol code
    701003.01.010
    Additional study identifiers
    ISRCTN number
    		 ISRCTN77419032
    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, Dr. Willmar Schwabe GmbH & Co. KG Clinical Research Department, +49 07214005573,
    Scientific contact
    Head of Clinical Research, Dr. Willmar Schwabe GmbH & Co. KG Clinical Research Department, +49 07214005573,
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Apr 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Apr 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of a treatment with EPs® 7630 syrup in comparison to EPs® 7630 solution in patients between 1 and 5 years old suffering from acute bronchitis.
    Protection of trial subjects
    Possibility to withdraw consent by subject. Monitoring of adverse Events and laboratory Parameters.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Nov 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: 602
    Worldwide total number of subjects
    602
    EEA total number of subjects
    602
    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)
    110
    Children (2-11 years)
    492
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects were recruited in 35 investigational sites. All 602 subjects were randomized.

    Pre-assignment period milestones
    Number of subjects started
    		 602
    Number of subjects completed
    		 602

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EPs® 7630 syrup
    Arm description
    		 100 g (= 93.985 ml) syrup contain: Herbal drug preparation from the roots of Pelargonium sidoides (1 : 8 - 10), dried. Eight randomized children were drop-outs without any intake of the investigational product. These subjects were excluded from the safety analysis set. The full analysis set corresponded with the safety analysis set.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    EPs® 7630 syrup
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 ml syrup three times daily for 7 consecutive days (SMC 7651, batch no. 0201101)

    Arm title
    		 EPs® 7630 solution
    Arm description
    		 10 g (= 9.75 mL) of oral solution contain 8.0 g herbal drug preparation from the roots of Pelargonium sidoides (1 : 8 - 10) (EPs® 7630) Three randomized children were drop-outs without any intake of the investigational product. These subjects were excluded from the safety analysis set. The full analysis set corresponded with the safety analysis set.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    EPs® 7630 solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    10 drops three times daily for 7 consecutive days (SMC 7521, batch no. 0201102)

    Number of subjects in period 1
    		EPs® 7630 syrup EPs® 7630 solution
    Started
    411
    191
    Completed
    387
    178
    Not completed
    24
    13
         Consent withdrawn by subject
    1
    3
         Adverse event, non-fatal
    4
    -
         Other specifications
    19
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EPs® 7630 syrup
    Reporting group description
    		 100 g (= 93.985 ml) syrup contain: Herbal drug preparation from the roots of Pelargonium sidoides (1 : 8 - 10), dried. Eight randomized children were drop-outs without any intake of the investigational product. These subjects were excluded from the safety analysis set. The full analysis set corresponded with the safety analysis set.

    Reporting group title
    EPs® 7630 solution
    Reporting group description
    		 10 g (= 9.75 mL) of oral solution contain 8.0 g herbal drug preparation from the roots of Pelargonium sidoides (1 : 8 - 10) (EPs® 7630) Three randomized children were drop-outs without any intake of the investigational product. These subjects were excluded from the safety analysis set. The full analysis set corresponded with the safety analysis set.

    Reporting group values
    		 EPs® 7630 syrup EPs® 7630 solution Total
    Number of subjects
    		 411 191 602
    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)
    		 73 37 110
        Children (2-11 years)
    		 338 154 492
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 3.03 ± 1.34 2.97 ± 1.39 -
    Gender categorical
    Units: Subjects
        Female
    		 192 86 278
        Male
    		 219 105 324
    Subject analysis sets

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set (SAF) included all subjects having taken their randomised EPs® 7630 medication at least once. The safety analysis set corresponded with the full analysis set (FAS). 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 condition 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.

    Subject analysis sets values
    		 Safety analysis set
    Number of subjects
    591
    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)
    108
        Children (2-11 years)
    483
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    3.01 ± 1.35
    Gender categorical
    Units: Subjects
        Female
    275
        Male
    316

    End points

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    End points reporting groups
    Reporting group title
    EPs® 7630 syrup
    Reporting group description
    		 100 g (= 93.985 ml) syrup contain: Herbal drug preparation from the roots of Pelargonium sidoides (1 : 8 - 10), dried. Eight randomized children were drop-outs without any intake of the investigational product. These subjects were excluded from the safety analysis set. The full analysis set corresponded with the safety analysis set.

    Reporting group title
    EPs® 7630 solution
    Reporting group description
    		 10 g (= 9.75 mL) of oral solution contain 8.0 g herbal drug preparation from the roots of Pelargonium sidoides (1 : 8 - 10) (EPs® 7630) Three randomized children were drop-outs without any intake of the investigational product. These subjects were excluded from the safety analysis set. The full analysis set corresponded with the safety analysis set.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set (SAF) included all subjects having taken their randomised EPs® 7630 medication at least once. The safety analysis set corresponded with the full analysis set (FAS). 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 condition 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.

    Primary: Number of subjects with adverse events related to gastrointestinal complaints

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    End point title
    		 Number of subjects with adverse events related to gastrointestinal complaints
    End point description
    Note: Number of subjects with adverse events related to gastrointestinal complaints is one of several pre-specified endpoints. See document for a complete description of the endpoints. Codes related to gastrointestinal complaints according to MedDRA Version 14: (10000059), (10000081), (10000084), (10000087), (10000133), (10010774), (10012735), (10013781), (10013911), (10013946), (10013950), (10014866), (10015137), (10016101), (10016766), (10017367), (10017888), (10017944), (10028813), (10030973), (10042101), (10043951), (10047700), (10048714), (10052402), (10053155), (10056819), (10060961)
    End point type
    Primary
    End point timeframe
    Baseline and End of Treatment (Day 7)
    End point values
    		 EPs® 7630 syrup EPs® 7630 solution
    Number of subjects analysed
    403
    188
    Units: Subjects
        Subjects affected
    13
    6
    Statistical analysis title
    		 Chi-squared test for risk difference
    Statistical analysis description
    For each of the treatment arms the relative frequencies of patients with AEs and adverse drug reactions of the mentioned system group are estimated. In addition a 95% confidence interval is calculated for the risk difference according to Newcombe.
    Comparison groups
    EPs® 7630 syrup v EPs® 7630 solution
    Number of subjects included in analysis
    591
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.982 [2]
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.0003
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.038
         upper limit
    		 0.0284
    Notes
    [1] - Difference between treatment arms
    [2] - two-sided

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    14 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    EPs(R) 7630 Syrup
    Reporting group description
    		 Pelargonium extract

    Reporting group title
    EPs(R) 7630 Solution
    Reporting group description
    		 Pelargonium extract

    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 were no preferred Terms affected by more than than frequeny threshold of 5%.
    Serious adverse events
    		 EPs(R) 7630 Syrup EPs(R) 7630 Solution
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 188 (0.53%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 403 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 EPs(R) 7630 Syrup EPs(R) 7630 Solution
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 403 (0.00%)
    0 / 188 (0.00%)

    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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