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:
    Triamcinolone levels in cochlear perilymph

    Summary
    EudraCT number
    		 2017-002377-19
    Trial protocol
    		 AT  
    Global end of trial date
    30 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Feb 2024
    First version publication date
    09 Feb 2024
    Other versions
    Summary report(s)
    		 Manuscript

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1456/2017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03248856
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Abteilung für Hals-, Nasen- und Ohrenkrankheiten MUW, AKH Wien
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria,
    Public contact
    HNO Ambulanz 8J, Abteilung für Hals-, Nasen- und Ohrenkrankheiten MUW, AKH Wien, valerie.dahm@meduniwien.ac.at
    Scientific contact
    HNO Ambulanz 8J, Abteilung für Hals-, Nasen- und Ohrenkrankheiten MUW, AKH Wien, valerie.dahm@meduniwien.ac.at
    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
    30 Apr 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective Demonstrate absorption of Triamcinolone acetonide in cochlear perilymph in comparison to dissemination to the blood circulation after intratympanic application
    Protection of trial subjects
    Case report forms will be copied and stored separately. Data will be double-checked and saved in an excel sheet on a computer to which only study personel has access to. Patients will be randomly assigned a three-digit number and the further data analysis will be carried out anonymously.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Oct 2017
    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
    Austria: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    35
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients scheduled for cochlear implantation will be asked to participate in the study. Inclusion and exclusion criteria will be evaluated at the ent outpatients department. If patients fulfill inclusion and exclusion criteria and consent to the study is given a reevaluation on day 0 will be carried out. If the second evaluation has a positive o

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 (TAC, 10 mg/mL, 24 h before sampling)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Triamcinolone acetonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratympanic use
    Dosage and administration details
    intratympanic 10mg/ml

    Arm title
    		 Group 2
    Arm description
    		 (TAC, 40 mg/mL, 24 h before sampling)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Triamcinolone acetonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratympanic use
    Dosage and administration details
    intratympanic 40mg/ml

    Arm title
    		 Group 3
    Arm description
    		 (TAC, 10 mg/mL, 1 h before sampling)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Triamcinolone acetonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratympanic use
    Dosage and administration details
    intratympanic 10mg/ml

    Arm title
    		 Group 4
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Triamcinolone acetonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratympanic use
    Dosage and administration details
    intratympanic 40mg/ml

    Number of subjects in period 1
    		Group 1 Group 2 Group 3 Group 4
    Started
    10
    10
    10
    10
    Completed
    10
    10
    10
    10

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Study patients
    Reporting group description
    		 -

    Reporting group values
    		 Study patients Total
    Number of subjects
    		 40 40
    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)
    		 35 35
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 20 20
        Male
    		 20 20

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 (TAC, 10 mg/mL, 24 h before sampling)

    Reporting group title
    Group 2
    Reporting group description
    		 (TAC, 40 mg/mL, 24 h before sampling)

    Reporting group title
    Group 3
    Reporting group description
    		 (TAC, 10 mg/mL, 1 h before sampling)

    Reporting group title
    Group 4
    Reporting group description
    		 -

    Primary: TRiamcinolone levels

    		 Close Top of page
    End point title
    		 TRiamcinolone levels
    End point description
    End point type
    Primary
    End point timeframe
    single measurement
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    10
    10
    10
    10
    Units: microgram(s)/microlitre
        number (not applicable)
    46.4
    96.8
    396.4
    329.4
    Attachments
    		 Untitled (Filename: Dahm V 2021 Evaluation of Levels of Triamcinolone Acetonide in Human Perilymph and Plasma After Intratympanic Application in Patients Receiving Cochlear Implants A Randomized Clinical Trial.pdf)
    Statistical analysis title
    		 statistical analysis
    Comparison groups
    Group 2 v Group 3 v Group 4 v Group 1
    Number of subjects included in analysis
    40
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Median difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    No adverse events reported
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 5%
    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 serious adverse events have been reported for intratympanic injection of triamcinolone acetonide

    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-Thu May 02 21:50:26 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA