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

Phase 1

Completed

• Conditions: Hearing Loss, Noise-Induced; Hearing Loss, Ototoxic; Meniere Disease; Hearing Loss, Sudden
• Interventions: Drug: Dexamethasone; Drug: Hyaluronic acid

• Registration Number: NCT04766853
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-23
• Study Start: 2021-07-22
• Primary Completion: 2023-04-18
• Status Verified: 2024-07
• Study Completion: 2024-07-19
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone+Saline	Dexamethasone	-
Dexamethasone+Hyaluronic Acid	Dexamethasone	-
Dexamethasone+Hyaluronic Acid	Hyaluronic acid	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of