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Completed

NCT Number: NCT04766853

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

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.

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Key information

Conditions

Hearing Loss, Sudden Ear Diseases Endolymphatic Hydrops Hearing Disorders Hearing Loss Hearing Loss, Noise-Induced Hearing Loss, Ototoxic Hearing Loss, Sensorineural Labyrinth Diseases Meniere Disease Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

Dexamethasone 5mg/ml

Hyaluronic acid

Drug

Hyaluronic Acid 20mg/2ml

Primary outcomes

  1. Verification of tympanic membrane with endoscopy (Safety)

    Time frame: 3-4 weeks after intratympanic injection

    Confirming healing time of perforation and inflammation

  2. Confirmation of inflammation and drug with CT imaging (Durability)

    Time frame: 1 day and/or 1 weeks after intratympanic injection

    Checking a time duration of drug in middle and inner ear

  3. Valuation of hearing threshold with Pure tone audiometry (Efficacy)

    Time frame: 3-4 weeks after intratympanic injection

    Verifying therapeutic effect of intratympanic drug delivery vehicle

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 23, 2021
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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