Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Safety and intake effect of EPs®7630 (an extract from the roots of Pelargonium sidoides)

    Summary
    EudraCT number
    		 2013-004977-28
    Trial protocol
    		 GB  
    Global end of trial date
    31 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jul 2018
    First version publication date
    01 Jul 2018
    Other versions
    Summary report(s)
    		 701079.01.013 Summary of results 2016_09_07

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    701079.01.013
    Additional study identifiers
    ISRCTN number
    		 ISRCTN35425744
    US NCT number
    		 NCT02174653
    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 Clinical Research, Dr. Willmar Schwabe GmbH & Co. KG, 0049 7214005573,
    Scientific contact
    Head Clinical Research, Dr. Willmar Schwabe GmbH & Co. KG, 0049 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
    29 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to investigate the occurrence of adverse drug reactions (ADRs) during the 4 months treatment, defined as the proportion of participants in each trial group with suspected adverse events.
    Protection of trial subjects
    Possibility to withdraw consent. Monitoring of adverse Events and laboratory Parameters.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Mar 2014
    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
    United Kingdom: 798
    Worldwide total number of subjects
    798
    EEA total number of subjects
    798
    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)
    797
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 n.a.

    Pre-assignment
    Screening details
    		 Seventy eight participants were not randomized and did not receive the investigational product since they did not fulfill all in-/exclusion criteria.

    Pre-assignment period milestones
    Number of subjects started
    		 798
    Number of subjects completed
    		 683

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screening Failures: 78
    Reason: Number of subjects
    		 No Intake of Study Medication: 37
    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, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EPs® 7630
    Arm description
    		 EPs® 7630 3x20 mg or 3x20/40 mg film-coated tablets
    Arm type
    		 Experimental

    Investigational medicinal product name
    EPs® 7630
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3x20 mg / 3x40 mg

    Arm title
    		 Placebo
    Arm description
    		 Placebo film-coated tablets
    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
    3x0 mg

    Number of subjects in period 1 [1]
    		EPs® 7630 Placebo
    Started
    460
    223
    Completed
    425
    213
    Not completed
    35
    10
         Adverse event, non-fatal
    2
    -
         Other
    10
    3
         Withdrawal of consent without giving the reason
    5
    -
         Lost to follow-up
    18
    7
    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: 78 Screening Failures and 37 subjects with no intake of study medication.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    EPs® 7630
    Reporting group description
    		 EPs® 7630 3x20 mg or 3x20/40 mg film-coated tablets

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo film-coated tablets

    Reporting group values
    		 EPs® 7630 Placebo Total
    Number of subjects
    		 460 223 683
    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)
    		 459 223 682
        From 65-84 years
    		 1 0 1
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 21.7 ( 6.6 ) 21 ( 5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 291 148 439
        Male
    		 169 75 244
    Subject analysis sets

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Analysis set

    Subject analysis sets values
    		 Safety analysis set
    Number of subjects
    683
    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)
    682
        From 65-84 years
    1
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    21.5 ( 6.1 )
    Gender categorical
    Units: Subjects
        Female
    439
        Male
    244

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    EPs® 7630
    Reporting group description
    		 EPs® 7630 3x20 mg or 3x20/40 mg film-coated tablets

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo film-coated tablets

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Analysis set

    Primary: Occurrence of adverse drug reactions (ADRs) during the 4 months treatment, defined as the proportion of participants in each trial group with suspected adverse events

    		 Close Top of page
    End point title
    		 Occurrence of adverse drug reactions (ADRs) during the 4 months treatment, defined as the proportion of participants in each trial group with suspected adverse events
    End point description
    Note: Occurrence of adverse drug reactions is the primary pre-specified endpoint. See document for a complete description of the endpoints.
    End point type
    Primary
    End point timeframe
    Baseline and End of Treatment (4 month Treatment Period)
    End point values
    		 EPs® 7630 Placebo Safety analysis set
    Number of subjects analysed
    460
    223
    683
    Units: Number of ADR
        number (not applicable)
    89
    43
    132
    Statistical analysis title
    		 Occurence of adverse drug reactions
    Comparison groups
    EPs® 7630 v Placebo
    Number of subjects included in analysis
    683
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Risk difference (RD) %
    Point estimate
    0.07
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 6.4

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    4 Months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    EPs®7630
    Reporting group description
    		 EPs®7630

    Serious adverse events
    		 Placebo EPs®7630
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 223 (0.00%)
    3 / 460 (0.65%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 460 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 460 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 460 (0.22%)
         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
    		 Placebo EPs®7630
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 223 (29.15%)
    135 / 460 (29.35%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    40 / 223 (17.94%)
    82 / 460 (17.83%)
         occurrences all number
    95
    198
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    14 / 223 (6.28%)
    36 / 460 (7.83%)
         occurrences all number
    27
    53
    Nausea
         subjects affected / exposed
    13 / 223 (5.83%)
    18 / 460 (3.91%)
         occurrences all number
    15
    28
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    13 / 223 (5.83%)
    20 / 460 (4.35%)
         occurrences all number
    20
    30
    Oropharyngeal pain
         subjects affected / exposed
    31 / 223 (13.90%)
    33 / 460 (7.17%)
         occurrences all number
    48
    49

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 03 01:35:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA