Status:
COMPLETED
Verification of the Efficacy/safety of the Intratympanic Drug Delivery for Hearing Loss
Lead Sponsor:
Seoul National University Hospital
Conditions:
Hearing Loss, Sudden
Hearing Loss, Ototoxic
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04766853
Start Date
July 22 2021
End Date
July 19 2024
Last Update
October 24 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea