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Trial record 6 of 927 for:    triamcinolone acetonide

Triamcinolone Levels in Cochlear Perilymph

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ClinicalTrials.gov Identifier: NCT03248856
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Christoph Arnoldner, Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Cochlear Hearing Loss Drug: Triamcinolone Acetonide Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Triamcinolone Levels in Cochlear Perilymph
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019


Arm Intervention/treatment
Group 1
Group 1 will receive triamcinolone acetonide 10mg 20 to 24hours before sampling.
Drug: Triamcinolone Acetonide
Intratympanic administration

Group 2
Group 2 will receive triamcinolone acetonide 40mg 20 to 24hours before sampling.
Drug: Triamcinolone Acetonide
Intratympanic administration

Group 3
Group 3 will receive triamcinolone acetonide 10mg 1 to 2 hours before sampling.
Drug: Triamcinolone Acetonide
Intratympanic administration

Group 4
Group 3 will receive triamcinolone acetonide 40mg 1 to 2 hours before sampling.
Drug: Triamcinolone Acetonide
Intratympanic administration




Primary Outcome Measures :
  1. Triamcinolone levels in comparison [ Time Frame: 2 years ]
    Absorption of Triamcinolone acetonide in cochlear perilymph in comparison to dissemination to the blood circulation


Secondary Outcome Measures :
  1. Triamcinolone stability [ Time Frame: 2 years ]
    The stability of triamcinolone acetonide levels in the cochlear perilymph

  2. Triamcinolone concentrations [ Time Frame: 2 years ]
    Perilymph concentrations and blood concentrations of triamcinolone acetonide after administration of different Triamcinolone acetonide doses.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248856


Locations
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Austria
Medical University of Vienna (AKH) Recruiting
Vienna, Austria, 1090
Contact: Valerie Dahm, MD    0043/1/40400 ext 33300    valerie.dahm@meduniwien.ac.at   
Principal Investigator: Christoph Arnoldner, Prof.         
Sponsors and Collaborators
Christoph Arnoldner

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Responsible Party: Christoph Arnoldner, Assoc Prof PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03248856     History of Changes
Other Study ID Numbers: 1456/2017
2017-002377-19 ( EudraCT Number )
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action