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Triamcinolone Levels in Cochlear Perilymph

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ClinicalTrials.gov Identifier: NCT03248856
Recruitment Status : Enrolling by invitation
First Posted : August 14, 2017
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Christoph Arnoldner, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE August 9, 2017
First Posted Date  ICMJE August 14, 2017
Last Update Posted Date June 25, 2020
Actual Study Start Date  ICMJE October 2, 2017
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2017)
Triamcinolone levels in comparison [ Time Frame: 2 years ]
Absorption of Triamcinolone acetonide in cochlear perilymph in comparison to dissemination to the blood circulation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2020)
  • Triamcinolone stability [ Time Frame: 2 years ]
    The stability of triamcinolone acetonide levels in the cochlear perilymph
  • Triamcinolone concentrations [ Time Frame: 2 years ]
    Perilymph concentrations and blood concentrations of triamcinolone acetonide after administration of different Triamcinolone acetonide doses.
  • Impedances [ Time Frame: 2 years ]
    Difference of impedances of patients receiving different doses at different timepoints
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2017)
  • Triamcinolone stability [ Time Frame: 2 years ]
    The stability of triamcinolone acetonide levels in the cochlear perilymph
  • Triamcinolone concentrations [ Time Frame: 2 years ]
    Perilymph concentrations and blood concentrations of triamcinolone acetonide after administration of different Triamcinolone acetonide doses.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Triamcinolone Levels in Cochlear Perilymph
Official Title  ICMJE Triamcinolone Levels in Cochlear Perilymph
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Cochlear Hearing Loss
Intervention  ICMJE Drug: Triamcinolone Acetonide
Intratympanic administration
Study Arms  ICMJE
  • Group 1
    Group 1 will receive triamcinolone acetonide 10mg 20 to 24hours before sampling.
    Intervention: Drug: Triamcinolone Acetonide
  • Group 2
    Group 2 will receive triamcinolone acetonide 40mg 20 to 24hours before sampling.
    Intervention: Drug: Triamcinolone Acetonide
  • Group 3
    Group 3 will receive triamcinolone acetonide 10mg 1 to 2 hours before sampling.
    Intervention: Drug: Triamcinolone Acetonide
  • Group 4
    Group 3 will receive triamcinolone acetonide 40mg 1 to 2 hours before sampling.
    Intervention: Drug: Triamcinolone Acetonide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: August 9, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients between 18 and 90 years will be included in the study, who will undergo a cochlear implantation and are willing to participate in the study

Exclusion Criteria:

  • Patients younger than 18 years
  • Patients who receive cortisone on a regular basis or receive cortisone i.v. or p.o. preoperatively
  • Patients with contraindications against the administration of Volon A
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03248856
Other Study ID Numbers  ICMJE 1456/2017
2017-002377-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Time Frame: January 2020
Responsible Party Christoph Arnoldner, Medical University of Vienna
Study Sponsor  ICMJE Christoph Arnoldner
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Vienna
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP