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

Seoul National University Hospital1 site in 1 country15 target enrollmentJuly 22, 2021

ConditionsHearing Loss, Sudden Hearing Loss, Ototoxic Hearing Loss, Noise-Induced Meniere Disease

InterventionsDexamethasone Hyaluronic acid

DrugsDexamethasone Hyaluronic acid

Overview

Phase: Phase 1
Intervention: Dexamethasone
Conditions: Hearing Loss, Sudden
Sponsor: Seoul National University Hospital
Enrollment: 15
Locations: 1
Primary Endpoint: Verification of tympanic membrane with endoscopy (Safety)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 22, 2021

End Date

July 19, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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.