- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04766853
Verification of the Efficacy/Safety of the Intratympanic Drug Delivery for Hearing Loss
April 17, 2024 updated by: Seoul National University Hospital
Verification of the Efficacy / Safety of the Intratympanic Drug Delivery Vehicle for Treating Intractable Hearing Loss (Pilot Study)
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
26
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Myung-Whan Suh
- Phone Number: +821039490330
- Email: drmung@naver.com
Study Contact Backup
- Name: Yu-Jung Hwang
- Email: eliteyujung@naver.com
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Seoul National University Hospital
-
Contact:
- Myung-Whan Suh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dexamethasone+Saline
|
Dexamethasone 5mg/ml
|
Experimental: Dexamethasone+Hyaluronic Acid
|
Dexamethasone 5mg/ml
Hyaluronic Acid 20mg/2ml
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Verification of tympanic membrane with endoscopy (Safety)
Time Frame: 3-4 weeks after intratympanic injection
|
Confirming healing time of perforation and inflammation
|
3-4 weeks after intratympanic injection
|
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
|
1 day and/or 1 weeks after intratympanic injection
|
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
|
3-4 weeks after intratympanic injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 22, 2021
Primary Completion (Actual)
April 18, 2023
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
February 17, 2021
First Submitted That Met QC Criteria
February 19, 2021
First Posted (Actual)
February 23, 2021
Study Record Updates
Last Update Posted (Actual)
April 18, 2024
Last Update Submitted That Met QC Criteria
April 17, 2024
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Otorhinolaryngologic Diseases
- Labyrinth Diseases
- Ear Diseases
- Sensation Disorders
- Hearing Disorders
- Hearing Loss, Sensorineural
- Endolymphatic Hydrops
- Hearing Loss
- Deafness
- Hearing Loss, Noise-Induced
- Hearing Loss, Sudden
- Meniere Disease
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protective Agents
- Adjuvants, Immunologic
- Viscosupplements
- Dexamethasone
- Hyaluronic Acid
Other Study ID Numbers
- H-1812-128-997
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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