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    Summary
    EudraCT Number:2015-002602-36
    Sponsor's Protocol Code Number:KKSH-127
    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:2016-03-08
    Trial 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 number2015-002602-36
    A.3Full title of the trial
    Efficacy and safety of high dose glucocorticosteroid treatment for idiopathic sudden sensorineural hearing loss (HODOKORT)
    Studie zur Wirksamkeit und Sicherheit der HOchDOsis-GlukoKORTikoid-Therapie beim akuten, idiopathischen, sensorineuralen Hörverlust (HODOKORT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of high dose glucocorticosteroid treatment for sudden hearing loss (HODOKORT)
    Studie zur Wirksamkeit und Sicherheit der HOchDOsis-GlukoKORTikoid-Therapie beim Hörsturz (HODOKORT)
    A.3.2Name or abbreviated title of the trial where available
    HODOKORT
    A.4.1Sponsor's protocol code numberKKSH-127
    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 SponsorMartin-Luther-Universität Halle-Wittenberg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFederal Ministry of Education and Research
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCoordinating Centre for Clinical Trials University of Halle (KKSH)
    B.5.2Functional name of contact pointKKSH
    B.5.3 Address:
    B.5.3.1Street Address06120
    B.5.3.2Town/ cityHalle (Saale)
    B.5.3.4CountryGermany
    B.5.4Telephone number++49+3455574920
    B.5.5Fax number++49+3455575210
    B.5.6E-mailhoersturz-studie@kks-halle.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 Prednisolut® 250 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMibe GmbH Arzneimittel
    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.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    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 Dexamethason 8 mg JENAPHARM®
    D.2.1.1.2Name of the Marketing Authorisation holdermibe GmbH Arzneimittel
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Prednisolon 20 mg JENAPHARM® Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holdermibe GmbH Arzneimittel
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    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 placeboPowder and solvent for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Idiopathic sudden sensorineural hearing loss
    Akuter, idiopathischer, sensorineuraler Hörverlust
    E.1.1.1Medical condition in easily understood language
    Hearing loss
    Hörsturz
    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
    To assess the efficacy (hearing threshold improvement) of high dose systemic glucocorticosteroids (“steroids”) versus standard of care (standard dose systemic steroids) for the treatment of unilateral idiopathic sudden sensorineural hearing loss, when given as a primary therapy
    Bestimmung der Wirksamkeit einer intravenösen oder oralen primären, systemischen Hochdosis-Glukokortikoid-Therapie im Vergleich zur Standarddosis-Therapie in der Behandlung des einseitigen, akuten, idiopathischen Hörverlustes („Hörsturz“)
    E.2.2Secondary objectives of the trial
    To assess the safety (hearing threshold improvement) of high dose systemic glucocorticosteroids (“steroids”) versus standard of care (standard dose systemic steroids) for the treatment of unilateral idiopathic sudden sensorineural hearing loss, when given as a primary therapy
    Bestimmung der Sicherheit einer intravenösen oder oralen primären, systemischen Hochdosis-Glukokortikoid-Therapie im Vergleich zur Standarddosis-Therapie in der Behandlung des einseitigen, akuten, idiopathischen Hörverlustes („Hörsturz“)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -female and male adults (18-80 years)
    -unilateral sensorineural hearing loss
    -sudden onset of hearing loss (occurring within 24 hours)
    -unknown etiology (no other ear or CNS disease)
    -change in hearing threshold due to ISSHL of 30 dB or higher (as compared to a pre-event audiogram, the audiogram of the unaffected ear, or the ISO) for the 3 most affected contiguous frequencies in the affected ear but not less then 50 dB absolute threshold as average of the 3 most affected contiguous frequencies between 0,25 und 8 kHz < 50 dB HL
    -enrolment and treatment within 7 days from onset
    -weibliche und männliche Erwachsene (18-80 Jahre)
    -einseitiger sensorineuraler Hörverlust
    -plötzliches Auftreten des Hörverlustes (innerhalb von 24 h)
    -unklare Ursache (keine andere Ohr- oder ZNS-Erkrankung)
    -Verschlechterung der Luftleitungs-Hörschwelle um 30 dB HL oder mehr für die 3 am meisten betroffenen benachbarten Frequenzen des betroffenen Ohres (bezogen auf das Audiogram vor dem Auftreten oder des gesunden Ohres oder Normal-Audiogramm nach DIN-ISO 7029) und absolute Hörschwelle von 50 dB HL oder mehr als Mittelwert der drei am meisten betroffenen benachbarten Frequenzen im Bereich zwischen 0,25 und 8 kHz
    -Einschluss und Behandlungsbeginn innerhalb von 7 Tagen nach Auftreten
    E.4Principal exclusion criteria
    -recurrent ISSHL at the affected side (< 12 months)
    -known other otologic cause of ISSHL (e.g.: middle ear disease; vestibular schwannoma; known fluctuating hearing loss; Meniere’s disease)
    -absolute hearing threshold as average of the 3 most affected contiguous frequencies between 0,25 und 8 kHz < 50 dB HL
    -certain systemic diseases (treatment for or chronically active infection such as HIV, hepatitis C or B, tuberculosis, hard to balance diabetes mellitus, ongoing immunosuppressive treatment for rheumatic or chronic inflammatory disease, unstable atherosclerotic disease, heart failure >NYHA II, suicidality, severe osteoporosis, active peptic ulcer, uncontrolled (syst. >180 mmHg or diast. >100 mmHg) arterial hypertension)
    -treated mental disorders or after surgical interventions in the last 6 weeks: inclusion only after critical evaluation by the investigator
    -pre-treatment of ISSHL with glucocorticosteroids or hyperbaric oxygen
    -conductive deafness (air-bone gap 4PTA0,5-4kHz >10 dB)
    -pregnancy or lactation
    -wiederholter Hörsturz auf betroffener Seite (< 12 Monate)
    -bekannte systemische oder otologische (z.B. Mittelohrer-krankung, Vestibularisschwannom, fluktuierender Hörverlust, Morbus Menière) Ursache des akuten Hörverlustes
    -durchschnittlicher Hörverlust (drei am meisten betroffene benachbarte Frequenzen im Bereich zwischen 0,25 und 8 kHz) < 50 dB HL
    -bestimmte systemische Erkrankungen (Behandlung oder chronische Infektion mit HIV, Hepatitis C oder B, Tuberkulose, schwer einstellbarer Diabetes mellitus, laufende immunsupprimierende Behandlung rheumatischer oder chronisch-entzündlicher Erkrankungen, instabile atherosklerotische Erkrankung, Herzinsuffizienz >NYHA II, Suizidalität, schwere Osteoporose, Ulkus gastrici sive duodeni, unkontrollierter Bluthochdruck (syst. >180 mmHg oder diast. >100 mmHg)
    -bei behandelten psychischen Störungen oder Erkrankungen oder nach chirurgischen Eingriffen in den letzten 6 Wochen: Einschluss nur nach kritischer Bewertung durch Prüfarzt
    -Vorbehandlung (spezifisch auf den Hörsturz gerichtete Vorbehandlung mit Glukokortikosteroiden oder hyperbarem Sauerstoff)
    -Schallleitungsschwerhörigkeit (Air-bone gap 4PTA0,5-4kHz >10 dB)
    -Schwangerschaft/ Stillzeit
    E.5 End points
    E.5.1Primary end point(s)
    Average change in hearing thresholds (pure-tone average of the 3 most affected contiguous frequencies)
    Durchschnittliche Änderung in der Hörschwelle (Reintonhörschwelle der 3 am stärksten betroffenen benachbarten Frequenzen)
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after enrolment
    30 Tage nach Einschluss
    E.5.2Secondary end point(s)
    -average change in pure tone hearing level (3PTA0,5-2kHz [Fletcher-Typ] und 4PTA0,5-4kHz) 30 days after enrolment
    -percentage of patients with complete, partial or no improvement of hearing
    -average change in percentage of ear-specific masked monosyllabic words understood correctly at 65 and 80 dB SPL
    -patient self evaluation, quality of life and communication competence (patient questionnaires)
    -percentage of patients needing a hearing aid/ cochlear implant
    -percentage of patients with new or worsened arterial hypertension at day 5 (office blood pressure >140 mmHg syst. or >90 mmHg diast. or both)
    -percentage of patients with altered glucose tolerance at day 5 (to be detected by HOMA-IR)
    -need for rescue therapy
    -occurrence and extent of tinnitus one and six month after enrolment
    -Durchschnittliche Änderung in der Reintonhörschwelle (3PTA0,5-2kHz [Fletcher-Typ] und 4PTA0,5-4kHz) 30 Tage nach Einschluss
    -Anteil der Patienten mit kompletter, partieller oder keiner Verbesserung des Hörvermögens
    -durchschnittliche Veränderung des Sprachverstehens mit dem betroffenen Ohr (Prozent korrekt verstandene Freiburger Einsilber bei 65 und 80 dB SPL)
    -Durchschnittliche Änderung in der Patientenselbsteinschätzung des allgemeinen Gesundheitszustandes, Lebensqualität und Kommunikationskompetenz (Fragebögen)
    -Anteil der Patienten, die ein Hörgerät/ Cochlea-Implantat benötigen
    -Patienten mit erworbenem oder verstärktem Bluthochdruck an Tag 5 (während der Visite >140 mmHg systolisch oder >90 mmHg diastolisch oder beides)
    -Anteil der Patienten mit veränderter Glukosetoleranz an Tag 5 (HOMA-IR)
    -Durchführung einer „Rettungstherapie“
    -Vorhandensein und Ausmaß des Tinnitus 30 Tage und 6 Monate nach Einschluss

    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days and 180 days after enrolment
    30 und 180 Tage nach Einschluss
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned42
    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 Yes
    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
    end of the trial is defined as the time point the data bank is locked. Justification for this definition: study-specific documentation has to be completed until this time-point
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    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: 156
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 156
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state312
    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)
    not different from the expected normal treatment of that condition, see protocol
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-05-20
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