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

NCT04766853 | Completed Phase 1

• 1 other identifier: H-1812-128-997
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hearing loss; Drug Delivery; Dexamethasone; Hyaluronic Acid; Intratympanic injection

Outcome Measures

Primary Outcomes (3)

• Verification of tympanic membrane with endoscopy (Safety)

  Confirming healing time of perforation and inflammation

  3-4 weeks after intratympanic injection

• 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

• Valuation of hearing threshold with Pure tone audiometry (Efficacy)

  Verifying therapeutic effect of intratympanic drug delivery vehicle

  3-4 weeks after intratympanic injection

Study Arms (2)

Dexamethasone+Saline

ACTIVE COMPARATOR

Drug: Dexamethasone

Dexamethasone+Hyaluronic Acid

EXPERIMENTAL

Drug: Dexamethasone; Drug: Hyaluronic acid

Interventions

Dexamethasone DRUG

Dexamethasone 5mg/ml

Dexamethasone+Hyaluronic Acid; Dexamethasone+Saline

Hyaluronic acid DRUG

Hyaluronic Acid 20mg/2ml

Dexamethasone+Hyaluronic Acid

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

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

Interventions

Dexamethasone; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hearing Loss, Sensorineural; Endolymphatic Hydrops; Labyrinth Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 23, 2021
• Study Start: July 22, 2021
• Primary Completion: April 18, 2023
• Study Completion: July 19, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-07

Locations

KR (1)