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

Seoul National University logo

Seoul National University

Status and phase

Completed
Phase 2
Phase 1

Conditions

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

Treatments

Drug: Dexamethasone
Drug: Hyaluronic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT04766853
H-1812-128-997

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

15 participants in 2 patient groups

Dexamethasone+Saline
Active Comparator group
Treatment:
Drug: Dexamethasone
Dexamethasone+Hyaluronic Acid
Experimental group
Treatment:
Drug: Hyaluronic acid
Drug: Dexamethasone

Trial contacts and locations

1

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Central trial contact

Yu-Jung Hwang; Myung-Whan Suh

Data sourced from clinicaltrials.gov

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