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    Summary
    EudraCT Number:2013-000614-38
    Sponsor's Protocol Code Number:MW010
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2013-000614-38
    A.3Full title of the trial
    Monocenter, prospective, randomized placebo-controlled, double blind phase II trial to evaluate protective effects of Gingko biloba extract EGb 761® on temporary hearing damage caused by noise.
    Monozentrische prospektive randomisierte Placebo-kontrollierte doppelblinde Phase II Studie zur Exploration protektiver Effekte des Ginkgo biloba Spezialextrakts EGb 761® vor einer vorübergehenden Hörschädigung durch Lärm.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Monocenter, prospective, randomized placebo-controlled, double blind phase II trial to evaluate protective effects of Gingko biloba extract EGb 761® on temporary hearing damage caused by noise.
    Monozentrische prospektive randomisierte Placebo-kontrollierte doppelblinde Phase II Studie zur Exploration protektiver Effekte des Ginkgo biloba Spezialextrakts EGb 761® vor einer vorübergehenden Hörschädigung durch Lärm.
    A.4.1Sponsor's protocol code numberMW010
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDr. Willmar Schwabe GmbH & Co. KG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDr. Willmar Schwabe GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Willmar Schwabe GmbH & Co. KG
    B.5.2Functional name of contact pointAbteilung Medizinische Wissenschaft
    B.5.3 Address:
    B.5.3.1Street AddressBunsenstrasse 6-10
    B.5.3.2Town/ cityEttlingen
    B.5.3.3Post code76275
    B.5.3.4CountryGermany
    B.5.4Telephone number+4907243106573
    B.5.5Fax number+4907243106578
    B.5.6E-mailmw010@schwabe.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tebonin® intens 120 mg
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Willmar Schwabe GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEGb 761®
    D.3.2Product code EGb 761®
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Auricular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEGb761
    D.3.9.1CAS number 122933-57-7
    D.3.9.2Current sponsor codeEGb761
    D.3.9.3Other descriptive nameStandardized GINGKO BILOBA Extract
    D.3.9.4EV Substance CodeSUB74840
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Noise induced hearing impairment (temporarily)
    Lärminduzierte Hörschäden (vorübergehend)
    E.1.1.1Medical condition in easily understood language
    Noise induced hearing impairment (temporarily)
    Lärminduzierte Hörschäden (vorübergehend)
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the efficacy of EGb 761® against temporary hearing impairment due to noise (bilaterally 5 minutes 110 dB broadband noise) in healthy subjects.
    Evaluation der Wirksamkeit von EGb 761® zum Schutz vor einer vorübergehenden Hörschädigung durch Lärm (beidseits 5 Minuten 110 dB SPL Breitbandrauschen) bei gesunden Probanden
    E.2.2Secondary objectives of the trial
    Tolerability and safety of EGb761(R) in healthy volunteers
    Sicherheit und Verträglichkeit von EGb 761® bei gesunden Probanden
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. healthy, normal hearing men aged between 18 and 25
    2. written informed consent
    3. Willingness and ability to perform all study relevant tests
    1.gesunde normalhörende Männer im Alter zwischen 18 und 25 Jahren
    2.schriftliche Einwilligung nach Aufklärung
    3.Bereitschaft und Fähigkeit, an allen studienspezifischen Maßnahmen teilzunehmen.
    E.4Principal exclusion criteria
    1. anamnestically noted hearing impairment, sudden deafness, accoustic trauma
    2. Tinnitus
    3. Estimated noise exposition (job, leisure) aboce the mean 85 dB 8 hours 5 days a week
    4. at the screening evaluated impairment of outer, middle or inner ear or hearing impairment such as middle ear effusion, auditory canal and/or tubal ventilation disorder, ear surgery in the past, horizontal timpani tube
    5. haemorrhagic diathesis, coagulation disorder
    6. Diseases influencing resorption
    7. Chronic, severe or acute gerneral diseases within 4 weeks prior to study start
    8. hypersensitivity against ingredients of the study medication
    9. Acute or chronic otological, neurological or psychiatric diseases within 12 weeks prior to study start
    10. Clinically relevant internal diseases with the exception of
    a) sufficient and stably treated thyroid dysfunction or struma
    11. clinically significant ECG -or laboratory abnormalities
    12. Substance misuse or addiction current or in medical history
    13. Participation in another clinical trial within 12 weeks prior to study start
    14. regular intake if medication, food supplements, vitamines or mineral products with the exceptions of
    a. thyroid hormones
    15. Concomitant medications from following substance classes
    a. corticosteroides (systemic)
    b.ASS or NSAR
    c. potentially ototoxic antibiotics
    d. Thromocyte aggregation inhibitors or anticoagulants
    e. Psychopharmaca (anti depressivs, anxiolytics, tranquilizer, hypnotics)
    f. Herbal drugs or food supplements on a herbal basis
    g. Minerals or vitamines
    h. Antihistaminics or Antiemetics with effect on the central nervous system
    16. Intake of Ginkgo Biloba product within 8 weeks prior to study start
    17. Planned surgery or hospitalization during study period
    18. Further facts, which question a study participation
    1.anamnestisch bekannter Hörschaden, Hörsturz oder Knalltrauma
    2.Tinnitus
    3.Geschätzte Lärmexposition (Beruf/Freizeit), die über der Schwelle von durchschnittlich 85 dB SPL über 8 Stunden an 5 Tagen die Woche liegt
    4.bei Screening festgestellte Erkrankung des äußeren, Mittel- oder Innenohres oder Hörstörung , z. B. Mittelohrerguss, Tubenbelüftungsstörung, stattgehabte Ohroperation, liegendes Paukenröhrchen
    5.Hämorrhagische Diathese, Gerinnungsstörung
    6.Erkrankungen, die die Resorption beeinträchtigen können
    7.Chronische, schwere oder akute Allgemeinerkrankung innerhalb der letzten 4 Wochen
    8.Überempfindlichkeit gegenüber einem der Inhaltsstoffe der Prüfmedikation
    9.Akute oder chronische otologische, neurologische oder psychiatrische Erkrankung innerhalb der letzten 12 Monate
    10.klinisch relevante internistische Erkrankung mit Ausnahme von
    a)ausreichend und stabil behandelter Schilddrüsenfunktionsstörung oder Struma
    11.klinisch signifikante EKG- oder Laborveränderungen
    12.Substanzmissbrauch oder -abhängigkeit aktuell oder in der Anamnese
    13.Teilnahme an einer anderen klinischen Prüfung in den letzten 12 Wochen
    14.Regelmäßige Einnahme von Medikamenten, Nahrungsergänzungsmitteln, Vitamin- oder Mineralstoffpräparaten mit Ausnahme von
    a)Schilddrüsenhormonpräparaten
    15.Begleitmedikation aus einer der folgenden Substanzklassen
    a)Systemische Corticosteroide
    b)ASS oder NSAR
    c)Potentiell ototoxische Antibiotika
    d)Thrombozythenaggregationshemmer oder Antikoagulantien
    e)Psychopharmaka (Antidepressiva, Anxiolytika, Tranquilizer, Hypnotika)
    f)Phytopharmaka oder pflanzliche Nahrungsergänzungsmittel
    g)Mineralstoff- oder Vitamin-Präparate
    h)ZNS-wirksame Antihistaminika oder Antiemetika
    16.Einnahme eines Ginkgo-biloba Präparats innerhalb der letzten acht Wochen
    17.geplanter operativer Eingriff oder Krankenhausaufenthalt im Studienzeitraum
    18.Andere Faktoren, die die Teilnahme an der Studie in Frage stellen (z. B. unzureichendes Verständnis von Wesen und Tragweite der Studie, unzureichende Kenntnisse der deutschen Sprache)
    E.5 End points
    E.5.1Primary end point(s)
    Mean increase of the auditory threshold at frequencies 3, 4, 6,8 , 10, 11.2 and 12.5 kHz between 1 and 8 minutes after acoustic irradiation
    Durchschnittlicher Anstieg der Hörschwelle an den Frequenzen 3, 4, 6,8 , 10, 11,2 und 12,5 kHz zwischen
    1 bis 8 Minuten nach Ende der Beschallung
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time of evaluation is visit 3 (after 26-30 days of study medication intake).
    Der Zeitpunkt der Evaluierung des Primären Endpunkts ist Visite 3 (nach 26-30 Tagen Einnahme der Studienmedikation)
    E.5.2Secondary end point(s)
    1) Decrease of the distorsion product-OAE
    2) Decrease of the contralateral suppression of the TEOAE
    3) Decrease of klick-evoked OAE amplitude (TEOAE)
    4) proportion of subjects with increased auditory threshold > 5dB at the frequencies 3, 4, 6, 8, 10, 11.2 or 12.5 kHz
    5) Adverse Events
    1) Abnahme der Distorsionsprodukt -OAE
    2) Abnahme der kontralateralen Supprimierbarkeit der TEOAE
    3) Abnahme der Klick-evozierten OAE-Amplitude (TEOAE)
    4) Anteil Probanden mit Hörschwellenanstieg > 5 dB an den Frequenzen 3, 4, 6,8, 10, 11,2 oder 12,5 kHz
    5) Unerwünschte Ereignisse
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Visit 3 (after 26-30 days of study medication intake) 1-10 minutes after acoustic irradiation, and visit 4 (after 4 weeks).
    2) Visit 3 (after 26-30 days of study medication intake) 1-10 minutes after acoustic irradiation, and visit 4 (after 4 weeks).
    3) Visit 3 (after 26-30 days of study medication intake)
    1-10 minutes after acoustic irradiation, and visit 4 (after 4 weeks).
    4) Visit 4 (after 4 weeks).
    5) Throughout the whole study period.
    1) Visite 3 (nach 26-30 Tagen Einnahme der Studienmedikation) 1-10 Minuten nach Ende der Beschallung, und Visite 4 (nach 4 Wochen).
    2) Visite 3 (nach 26-30 Tagen Einnahme der Studienmedikation) 1-10 Minuten nach Ende der Beschallung, und Visite 4 (nach 4 Wochen).
    3) Visite 3 (nach 26-30 Tagen Einnahme der Studienmedikation) 1-10 Minuten nach Ende der Beschallung, und Visite 4 (nach 4 Wochen).
    4) Visite 4 (nach 4 Wochen).
    5) über den gesamten Studienzeitraum
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 202
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state202
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None, as the trial is conducted in healthy volunteers.
    Keine, da die Studie bei gesunden Freiwilligen durchgeführt wird.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
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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
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