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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04766853
Recruitment Status : Recruiting
First Posted : February 23, 2021
Last Update Posted : August 16, 2021
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
This study is a prospective, randomized pilot study. To verify an efficacy and safety of the dual drug injectable delivery vehicle, patients who have not responded to the existing standard treatment will be enrolled. Hearing test and endoscopy of tympanic membrane will be conducted after intratympanic treatment for evaluation.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Verification of the Efficacy / Safety of the Dual Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss (Pilot Study)
Actual Study Start Date : July 22, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Active Comparator: Dexamethasone Drug: Dexamethasone
Dexamethasone 5mg/ml

Experimental: Dexamethasone+Hyaluronic Acid Drug: Dexamethasone
Dexamethasone 5mg/ml

Drug: Hyaluronic acid
Dexamethasone+Hyaluronic Acid

Primary Outcome Measures :
  1. Verification of tympanic membrane with endoscopy (Safety) [ Time Frame: within 2 weeks after intratympanic injection ]
    Confirming healing time of perforation and inflammation

  2. Confirmation of inflammation and drug with x-ray or CT imaging (Durability) [ Time Frame: within 2 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: 1 month after intratympanic injection ]
    Verifying therapeutic effect of intratympanic drug delivery vehicle

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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 substance of this drug

Information from the National Library of Medicine

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 identifier (NCT number): NCT04766853

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Contact: Myung-Whan Suh +821039490330
Contact: Yu-Jung Hwang

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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Myung-Whan Suh         
Sponsors and Collaborators
Seoul National University Hospital
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Responsible Party: Seoul National University Hospital Identifier: NCT04766853    
Other Study ID Numbers: H-1812-128-997
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: August 16, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seoul National University Hospital:
Hearing loss
Drug Delivery
Hyaluronic Acid
Intratympanic injection
Additional relevant MeSH terms:
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Hearing Loss
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
Hyaluronic Acid
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Adjuvants, Immunologic
Immunologic Factors