Verification of the Efficacy/safety of the Intratympanic Drug Delivery for Hearing Loss

October 22, 2024 updated by: Seoul National University Hospital

Verification of the Efficacy / Safety of the Intratympanic Drug Delivery Vehicle for Treating Intractable Hearing Loss (pilot Study)

This study is a prospective, randomized pilot study. To verify an efficacy and safety of the Intratympanic drug delivery vehicle, patients who have not responded to the existing standard treatment will be enrolled. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Sudden hearing loss, ototoxic hearing loss, noise-induced hearing loss, meniere's disease patients with 25dB HL in pure tone audiometry
  • Patients whose hearing has not been restored after standard treatment
  • Patients do not participate in clinical trials within 6 months

Exclusion Criteria:

  • Patients with retrocochlear lesion
  • Patients with history of hypersensitivity to the ingredients of this drug
  • Patients with end-stage renal disease, end-stage liver disease, cardiovascular surgery, progressive brain tumor, progressive palsy and progressive stroke, etc. severe brain disease or cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone+Saline
Drug: Dexamethasone
Dexamethasone 5mg/ml
Experimental: Dexamethasone+Hyaluronic Acid
Drug: Dexamethasone
Dexamethasone 5mg/ml
Drug: Hyaluronic acid
Hyaluronic Acid 20mg/2ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verification of tympanic membrane with endoscopy (Safety)
Time Frame: 3-4 weeks after intratympanic injection
Confirming healing time of perforation and inflammation
3-4 weeks after intratympanic injection
Confirmation of inflammation and drug with CT imaging (Durability)
Time Frame: 1 day and/or 1 weeks after intratympanic injection
Checking a time duration of drug in middle and inner ear
1 day and/or 1 weeks after intratympanic injection
Valuation of hearing threshold with Pure tone audiometry (Efficacy)
Time Frame: 3-4 weeks after intratympanic injection
Verifying therapeutic effect of intratympanic drug delivery vehicle
3-4 weeks after intratympanic injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2021

Primary Completion (Actual)

April 18, 2023

Study Completion (Actual)

July 19, 2024

Study Registration Dates

First Submitted

February 17, 2021

First Submitted That Met QC Criteria

February 19, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

October 24, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1812-128-997

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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