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NCT04766853 Clinical Trial

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

Meniere Disease Clinical Trial

Official title:
Verification of the Efficacy / Safety of the Intratympanic Drug Delivery Vehicle for Treating Intractable Hearing Loss (Pilot Study)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04766853
Other study ID # H-1812-128-997
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 22, 2021
Est. completion date September 1, 2024

Study information
Verified date August 2023
Source Seoul National University Hospital
Contact Myung-Whan Suh
Phone +821039490330
Email drmung@naver.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 26
Est. completion date September 1, 2024
Est. primary completion date April 18, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Dexamethasone
Dexamethasone 5mg/ml
• Hyaluronic acid
Hyaluronic Acid 20mg/2ml

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

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