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   43850   clinical trials with a EudraCT protocol, of which   7282   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:
    Clinical Trial to Explore Treatment Effects of Ginkgo biloba Extract EGb 761® in Patients with Chronic Tinnitus and Effect Modification by Etiology, Biological Factors and Concomitant Pathologies.

    Summary
    EudraCT number
    		 2016-000315-32
    Trial protocol
    		 PL  
    Global end of trial date
    19 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jul 2019
    First version publication date
    14 Jul 2019
    Other versions
    Summary report(s)
    		 523079.01113_Summary of result_V1.0

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    523079.01.113
    Additional study identifiers
    ISRCTN number
    		 ISRCTN83863387
    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 Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, 0049 7214005573,
    Scientific contact
    Head Clinical Research Department, 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
    25 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To explore whether causes, risk factors, chronicity, characteristics of tinnitus and accompanying features influence the treatment effect of EGb 761® in terms of improvement and response rates • To identify groups of patients that benefit most from EGb 761®
    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
    28 Oct 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
    Poland: 187
    Worldwide total number of subjects
    187
    EEA total number of subjects
    187
    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)
    154
    From 65 to 84 years
    33
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects were recruited in twelve investigational sites in Poland.

    Pre-assignment
    Screening details
    		 Eleven patients did not receive the investigational product since they were classified as screening failures.

    Pre-assignment period milestones
    Number of subjects started
    		 187
    Number of subjects completed
    		 176

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screening Failures: 11
    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Baseline
    Arm description
    		 Baseline before starting treatment with EGb 761®
    Arm type
    		 Baseline

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 EGb 761®
    Arm description
    		 Investigational medical product containing EGb 761®, two film-coated tablets of 120 mg Ginkgo biloba extract
    Arm type
    		 Experimental

    Investigational medicinal product name
    EGb 761®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 film-coated tablet 2 times per day for 24 consecutive weeks

    Number of subjects in period 1
    		Baseline EGb 761®
    Started
    176
    176
    Completed
    176
    160
    Not completed
    0
    16
         Consent withdrawn by subject
    -
    2
         Adverse event, non-fatal
    -
    4
         Laboratory results at baseline
    -
    1
         Lost to follow-up
    -
    5
         Lack of efficacy
    -
    4

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups [1]
    Reporting group title
    Treatment period (overall period)
    Reporting group description
    		 In total, 176 subjects received the investigational treatment.

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: In total, 11 of the 187 subjects screened for inclusion into the study were not included into the baseline period.
    Reporting group values
    		 Treatment period (overall period) Total
    Number of subjects
    		 176 176
    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)
    		 148 148
        From 65-84 years
    		 28 28
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.3 ± 13.0 -
    Gender categorical
    Units: Subjects
        Female
    		 65 65
        Male
    		 111 111
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) includes all patients who took EGb 761® treatment and have at least one value of one of the most important variables to describe treatment effects assessed after baseline.

    Subject analysis set title
    Safety Evaluation Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety evaluable set (SES) comprises all patients having taken at least one tablet of EGb 761® .

    Subject analysis sets values
    		 Full Analysis Set Safety Evaluation Set
    Number of subjects
    170
    176
    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)
    142
    148
        From 65-84 years
    28
    28
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    51.6 ± 13.0
    51.3 ± 13.0
    Gender categorical
    Units: Subjects
        Female
    62
    65
        Male
    108
    111

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 Baseline before starting treatment with EGb 761®

    Reporting group title
    EGb 761®
    Reporting group description
    		 Investigational medical product containing EGb 761®, two film-coated tablets of 120 mg Ginkgo biloba extract

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) includes all patients who took EGb 761® treatment and have at least one value of one of the most important variables to describe treatment effects assessed after baseline.

    Subject analysis set title
    Safety Evaluation Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety evaluable set (SES) comprises all patients having taken at least one tablet of EGb 761® .

    Primary: Primary end point

    		 Close Top of page
    End point title
    		 Primary end point [1]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Week 0 - week 24
    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
    		 Baseline EGb 761®
    Number of subjects analysed
    170
    170
    Units: points
        median (inter-quartile range (Q1-Q3))
    9999.99 (9999.99 to 9999.99)
    9999.99 (9999.99 to 9999.99)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    27 weeks.
    Adverse event reporting additional description
    Non-serious adverse events occurred in 37 patients. However, no incidence of preferred terms of adverse events was higher than the threshold of 5%.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    EGb 761®
    Reporting group description
    		 Study Medication.

    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: No adverse events (AE) with an incidence higher than the threshold of 5% occurred during the trial.
    Serious adverse events
    		 EGb 761®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 176 (0.57%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 EGb 761®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 176 (0.00%)

    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 Apr 19 17:38:30 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA