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

NCT ID: NCT04766853

Last Updated: 2024-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-22

Study Completion Date

2024-07-19

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Dexamethasone+Saline

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone 5mg/ml

Dexamethasone+Hyaluronic Acid

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Dexamethasone 5mg/ml

Hyaluronic acid

Intervention Type DRUG

Hyaluronic Acid 20mg/2ml

Interventions

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Dexamethasone

Dexamethasone 5mg/ml

Intervention Type DRUG

Hyaluronic acid

Hyaluronic Acid 20mg/2ml

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-1812-128-997

Identifier Type: -

Identifier Source: org_study_id

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