Verification of the Efficacy/safety of the Intratympanic Drug Delivery for Hearing Loss
NCT04766853 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2024-10-24
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.
Conditions
- Hearing Loss, Sudden
- Hearing Loss, Ototoxic
- Hearing Loss, Noise-Induced
- Meniere Disease
Interventions
- DRUG
-
Dexamethasone 5mg/ml
- DRUG
-
Hyaluronic acid
Hyaluronic Acid 20mg/2ml
Sponsors & Collaborators
-
Seoul National University Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-22
- Primary Completion
- 2023-04-18
- Completion
- 2024-07-19
Countries
- South Korea
Study Locations
More Related Trials
-
FX-322 in Adults With Age-Related Sensorineural Hearing Loss
NCT04601909 ·Status: COMPLETED ·Phase: PHASE1
-
Sudden Hearing Loss Multi-center Clinical Trial
NCT02026479 ·Status: UNKNOWN ·Phase: NA
-
Intratympanic Injection of Dexamethasone With Hyaluronic Acid in Treatment of Sudden Sensorineural Hearing Loss
NCT06878599 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
NCT01588925 ·Status: COMPLETED ·Phase: PHASE2
-
Sudden Deafness Treatment Trial
NCT00097448 ·Status: COMPLETED ·Phase: PHASE3
-
FX-322 in Adults With Severe Sensorineural Hearing Loss
NCT04629664 ·Status: COMPLETED ·Phase: PHASE1
-
Noise-Induced Hearing Loss-Acute Exposure Treatment
NCT04768569 ·Status: TERMINATED ·Phase: PHASE2
-
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss
NCT04462198 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
NCT06968507 ·Status: RECRUITING ·Phase: PHASE4
-
A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
NCT06249919 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Effectiveness of Intratympanic Dexamethasone With Ligmocaine for Alleviation of Tinnitus
NCT04798391 ·Status: UNKNOWN ·Phase: PHASE4
-
First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss
NCT05664100 ·Status: TERMINATED ·Phase: PHASE1
-
Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)
NCT04774250 ·Status: TERMINATED ·Phase: PHASE2
-
Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells
NCT04397354 ·Status: COMPLETED ·Phase: NA
-
A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults
NCT07338864 ·Status: NOT_YET_RECRUITING
-
A Clinical Trial of the Safety and Efficacy of TJ0113 Capsules in the Treatment of Patients With Age-related Hearing Loss
NCT07012746 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
High Dose Oral Steroids in Sudden Sensorineural Hearing Loss
NCT03255473 ·Status: WITHDRAWN ·Phase: PHASE2
-
OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
NCT04129775 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Prevention of Noise-induced Hearing Loss
NCT02049073 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
FX-322 in Adults With Acquired Sensorineural Hearing Loss
NCT05086276 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of Adding Lidocaine to Dexamethasone in Intra-tympanic Injection for Management of Tinnitus
NCT03265197 ·Status: COMPLETED ·Phase: PHASE1
-
Establishment of a Trans-round Window Inner Ear Continuous Drug Delivery System for the Treatment of Severe-to-profound Sudden Sensorineural Hearing Loss
NCT05455398 ·Status: UNKNOWN ·Phase: NA
-
FX-322 in Adults With Stable Sensorineural Hearing Loss
NCT04120116 ·Status: COMPLETED ·Phase: PHASE2
-
Single-Sided Deafness and Asymmetric Hearing Loss
NCT04506853 ·Status: RECRUITING ·Phase: NA
-
Evaluating Possible Improvement in Speech and Hearing Tests After 28 Days of Dosing of the Study Drug AUT00063 Compared to Placebo (QuicKfire)
NCT02832128 ·Status: COMPLETED ·Phase: PHASE2