Verification of the Efficacy/Safety of the Intratympanic Drug Delivery for Hearing Loss
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ClinicalTrials.gov Identifier: NCT04766853 |
Recruitment Status :
Recruiting
First Posted : February 23, 2021
Last Update Posted : July 22, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hearing Loss, Sudden Hearing Loss, Ototoxic Hearing Loss, Noise-Induced Meniere Disease | Drug: Dexamethasone Drug: Hyaluronic acid | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Treatment |
Official Title: | Verification of the Efficacy / Safety of the Intratympanic Drug Delivery Vehicle for Treating Intractable Hearing Loss (Pilot Study) |
Actual Study Start Date : | July 22, 2021 |
Estimated Primary Completion Date : | February 2023 |
Estimated Study Completion Date : | February 2024 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Dexamethasone+Saline |
Drug: Dexamethasone
Dexamethasone 5mg/ml |
Experimental: Dexamethasone+Hyaluronic Acid |
Drug: Dexamethasone
Dexamethasone 5mg/ml Drug: Hyaluronic acid Hyaluronic Acid 20mg/2ml |
- Verification of tympanic membrane with endoscopy (Safety) [ Time Frame: 3-4 weeks after intratympanic injection ]Confirming healing time of perforation and inflammation
- 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
- 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

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04766853
Contact: Myung-Whan Suh | +821039490330 | drmung@naver.com | |
Contact: Yu-Jung Hwang | eliteyujung@naver.com |
Korea, Republic of | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Myung-Whan Suh |
Responsible Party: | Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT04766853 |
Other Study ID Numbers: |
H-1812-128-997 |
First Posted: | February 23, 2021 Key Record Dates |
Last Update Posted: | July 22, 2022 |
Last Verified: | July 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hearing loss Drug Delivery Dexamethasone Hyaluronic Acid Intratympanic injection |
Hearing Loss Deafness Meniere Disease Hearing Loss, Noise-Induced Hearing Loss, Sudden Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Endolymphatic Hydrops Labyrinth Diseases Hearing Loss, Sensorineural Dexamethasone |
Hyaluronic Acid Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Adjuvants, Immunologic Immunologic Factors Viscosupplements |