Back to resultsVerification of the Efficacy/Safety of the Intratympanic Drug Delivery for Hearing Loss
Primary Purpose
Hearing Loss, Sudden, Hearing Loss, Ototoxic, Hearing Loss, Noise-Induced
Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexamethasone
Hyaluronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Sudden focused on measuring Hearing loss, Drug Delivery, Dexamethasone, Hyaluronic Acid, Intratympanic injection
Eligibility 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.
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Dexamethasone+Saline
Dexamethasone+Hyaluronic Acid
Arm Description
Outcomes
Primary Outcome Measures
Verification of tympanic membrane with endoscopy (Safety)
Confirming healing time of perforation and inflammation
Confirmation of inflammation and drug with CT imaging (Durability)
Checking a time duration of drug in middle and inner ear
Valuation of hearing threshold with Pure tone audiometry (Efficacy)
Verifying therapeutic effect of intratympanic drug delivery vehicle
Secondary Outcome Measures
Full Information
NCT ID
NCT04766853
First Posted
February 17, 2021
Last Updated
August 28, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04766853
Brief Title
Verification of the Efficacy/Safety of the Intratympanic Drug Delivery for Hearing Loss
Official Title
Verification of the Efficacy / Safety of the Intratympanic Drug Delivery Vehicle for Treating Intractable Hearing Loss (Pilot Study)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sudden, Hearing Loss, Ototoxic, Hearing Loss, Noise-Induced, Meniere Disease
Keywords
Hearing loss, Drug Delivery, Dexamethasone, Hyaluronic Acid, Intratympanic injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone+Saline
Arm Type
Active Comparator
Arm Title
Dexamethasone+Hyaluronic Acid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 5mg/ml
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid
Intervention Description
Hyaluronic Acid 20mg/2ml
Primary Outcome Measure Information:
Title
Verification of tympanic membrane with endoscopy (Safety)
Description
Confirming healing time of perforation and inflammation
Time Frame
3-4 weeks after intratympanic injection
Title
Confirmation of inflammation and drug with CT imaging (Durability)
Description
Checking a time duration of drug in middle and inner ear
Time Frame
1 day and/or 1 weeks after intratympanic injection
Title
Valuation of hearing threshold with Pure tone audiometry (Efficacy)
Description
Verifying therapeutic effect of intratympanic drug delivery vehicle
Time Frame
3-4 weeks after intratympanic injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myung-Whan Suh
Phone
+821039490330
Email
drmung@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Jung Hwang
Email
eliteyujung@naver.com
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung-Whan Suh
12. IPD Sharing Statement
Learn more about this trial
Verification of the Efficacy/Safety of the Intratympanic Drug Delivery for Hearing Loss
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