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Verification of the Efficacy/Safety of the Intratympanic 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.
 
ClinicalTrials.gov Identifier: NCT04766853
Recruitment Status : Recruiting
First Posted : February 23, 2021
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Study Description
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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.

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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


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

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04766853


Contacts
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Contact: Myung-Whan Suh +821039490330 drmung@naver.com
Contact: Yu-Jung Hwang eliteyujung@naver.com

Locations
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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
More Information
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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

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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
Dexamethasone
Hyaluronic Acid
Intratympanic injection
Additional relevant MeSH terms:
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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