<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03248856</url>
  </required_header>
  <id_info>
    <org_study_id>1456/2017</org_study_id>
    <secondary_id>2017-002377-19</secondary_id>
    <nct_id>NCT03248856</nct_id>
  </id_info>
  <brief_title>Triamcinolone Levels in Cochlear Perilymph</brief_title>
  <official_title>Triamcinolone Levels in Cochlear Perilymph</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christoph Arnoldner</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study Triamcinolone acetonide will be applied intratympanically before cochlear&#xD;
      implant surgery. After round window exposure, a perilymph sample and simultaneously a blood&#xD;
      sample will be drawn. Triamcinolone levels will then be analyzed in the samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the ENT department of the university hospital Vienna (AKH Wien) patients are treated with&#xD;
      intratympanic triamcinolone acetonide before cochlea implantation to reduce inflammation and&#xD;
      in some cases to protect residual hearing. Triamcinolone acetonide levels in cochlear&#xD;
      perilymph will be evaluated in an open prospective clinical study. Patients scheduled for&#xD;
      cochlear implant surgery between 18 and 90 years will be included. Patients who are treated&#xD;
      with steroids preoperatively will be excluded from the study. Patients will be randomized&#xD;
      after inclusion to one of four groups. The randomization is carried out to generate&#xD;
      hypothesis for the needed dose and best time of application in the future. Triamcinolone&#xD;
      acetonide will then be applied 20-24h before surgery or at the beginning of the surgery,&#xD;
      depending on randomization (see below). About 20 µl of perilymph will be sampled&#xD;
      simultaneously to a blood sample during cochlear implant surgery.&#xD;
&#xD;
      The probes will be stored at -80°C. Triamcinolone acetonide levels of the blood and perilymph&#xD;
      will be determined by the pharmaceutical laboratory (Department of Pharmaceutical Technology&#xD;
      and Biopharmaceutics, University of Vienna).&#xD;
&#xD;
      The patients will be randomized to 4 groups. Group 1 - Volon A 10mg administration 20 - 24&#xD;
      hours before sampling. Group 2 - Volon A 40mg administration 20 - 24 hours before sampling.&#xD;
      Group 3 Volon A 10mg - administration 1 to 2 hours before sampling. Group 4 - Volon A 40mg&#xD;
      administration 1 to 2 hours before sampling.&#xD;
&#xD;
      The time interval of application (1 to 2 hours and 20 to 24 hours before sampling) are a&#xD;
      result of varying time of surgery depending on surgeons and patient anatomy as well as day to&#xD;
      day clinical organization. Patients can withdraw consent at any time of the study.&#xD;
&#xD;
      The active phase of each patient will be between 6 and 9 days depending on time of follow-up&#xD;
      visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Triamcinolone levels in comparison</measure>
    <time_frame>2 years</time_frame>
    <description>Absorption of Triamcinolone acetonide in cochlear perilymph in comparison to dissemination to the blood circulation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Triamcinolone stability</measure>
    <time_frame>2 years</time_frame>
    <description>The stability of triamcinolone acetonide levels in the cochlear perilymph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triamcinolone concentrations</measure>
    <time_frame>2 years</time_frame>
    <description>Perilymph concentrations and blood concentrations of triamcinolone acetonide after administration of different Triamcinolone acetonide doses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impedances</measure>
    <time_frame>2 years</time_frame>
    <description>Difference of impedances of patients receiving different doses at different timepoints</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cochlear Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group 1 will receive triamcinolone acetonide 10mg 20 to 24hours before sampling.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group 2 will receive triamcinolone acetonide 40mg 20 to 24hours before sampling.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group 3 will receive triamcinolone acetonide 10mg 1 to 2 hours before sampling.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group 3 will receive triamcinolone acetonide 40mg 1 to 2 hours before sampling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone Acetonide</intervention_name>
    <description>Intratympanic administration</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between 18 and 90 years will be included in the study, who will undergo a&#xD;
             cochlear implantation and are willing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years&#xD;
&#xD;
          -  Patients who receive cortisone on a regular basis or receive cortisone i.v. or p.o.&#xD;
             preoperatively&#xD;
&#xD;
          -  Patients with contraindications against the administration of Volon A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of Vienna (AKH)</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>September 25, 2021</last_update_submitted>
  <last_update_submitted_qc>September 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Christoph Arnoldner</investigator_full_name>
    <investigator_title>Assoc Prof PD Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Hearing Loss, Sensorineural</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Triamcinolone hexacetonide</mesh_term>
    <mesh_term>Triamcinolone diacetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>January 2020</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03248856
org study id: 1456/2017
secondary id: 2017-002377-19
nct id: NCT03248856
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
In this study Triamcinolone acetonide will be applied intratympanically before cochlear
      implant surgery. After round window exposure, a perilymph sample and simultaneously a blood
      sample will be drawn. Triamcinolone levels will then be analyzed in the samples.
At the ENT department of the university hospital Vienna (AKH Wien) patients are treated with
      intratympanic triamcinolone acetonide before cochlea implantation to reduce inflammation and
      in some cases to protect residual hearing. Triamcinolone acetonide levels in cochlear
      perilymph will be evaluated in an open prospective clinical study. Patients scheduled for
      cochlear implant surgery between 18 and 90 years will be included. Patients who are treated
      with steroids preoperatively will be excluded from the study. Patients will be randomized
      after inclusion to one of four groups. The randomization is carried out to generate
      hypothesis for the needed dose and best time of application in the future. Triamcinolone
      acetonide will then be applied 20-24h before surgery or at the beginning of the surgery,
      depending on randomization (see below). About 20 µl of perilymph will be sampled
      simultaneously to a blood sample during cochlear implant surgery.

      The probes will be stored at -80°C. Triamcinolone acetonide levels of the blood and perilymph
      will be determined by the pharmaceutical laboratory (Department of Pharmaceutical Technology
      and Biopharmaceutics, University of Vienna).

      The patients will be randomized to 4 groups. Group 1 - Volon A 10mg administration 20 - 24
      hours before sampling. Group 2 - Volon A 40mg administration 20 - 24 hours before sampling.
      Group 3 Volon A 10mg - administration 1 to 2 hours before sampling. Group 4 - Volon A 40mg
      administration 1 to 2 hours before sampling.

      The time interval of application (1 to 2 hours and 20 to 24 hours before sampling) are a
      result of varying time of surgery depending on surgeons and patient anatomy as well as day to
      day clinical organization. Patients can withdraw consent at any time of the study.

      The active phase of each patient will be between 6 and 9 days depending on time of follow-up
      visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Triamcinolone levels in comparison
time frame: 2 years
description: Absorption of Triamcinolone acetonide in cochlear perilymph in comparison to dissemination to the blood circulation
measure: Triamcinolone stability
time frame: 2 years
description: The stability of triamcinolone acetonide levels in the cochlear perilymph
measure: Triamcinolone concentrations
time frame: 2 years
description: Perilymph concentrations and blood concentrations of triamcinolone acetonide after administration of different Triamcinolone acetonide doses.
measure: Impedances
time frame: 2 years
description: Difference of impedances of patients receiving different doses at different timepoints
arm group label: Group 1
arm group type: Other
description: Group 1 will receive triamcinolone acetonide 10mg 20 to 24hours before sampling.
arm group label: Group 2
arm group type: Other
description: Group 2 will receive triamcinolone acetonide 40mg 20 to 24hours before sampling.
arm group label: Group 3
arm group type: Other
description: Group 3 will receive triamcinolone acetonide 10mg 1 to 2 hours before sampling.
arm group label: Group 4
arm group type: Other
description: Group 3 will receive triamcinolone acetonide 40mg 1 to 2 hours before sampling.
intervention type: Drug
intervention name: Triamcinolone Acetonide
description: Intratympanic administration
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Austria
responsible party type: Sponsor-Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Christoph Arnoldner
investigator title: Assoc Prof PD Dr.
mesh term: Hearing Loss
mesh term: Hearing Loss, Sensorineural
mesh term: Triamcinolone
mesh term: Triamcinolone Acetonide
mesh term: Triamcinolone hexacetonide
mesh term: Triamcinolone diacetate
sharing ipd: Yes
ipd info type: Study Protocol
ipd time frame: January 2020