Verification of the Efficacy/safety of the Intratympanic... | NCT04766853

Studies
Verification of the Efficacy/safety of the Intratympanic Drug Delivery for Hearing Loss

NCT04766853

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Oct 24, 2024Actual

Enrollment

15Actual

Phase

Phase 1Phase 2

Conditions

Hearing Loss, Sudden
Hearing Loss, Ototoxic
Hearing Loss, Noise-Induced
Meniere Disease

Interventions

Dexamethasone
Hyaluronic acid

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 22, 2021Actual

Primary Completion Date

Apr 18, 2023Actual

Completion Date

Jul 19, 2024Actual

First Submitted Date

Feb 17, 2021

First Submission Date that Met QC Criteria

Feb 19, 2021

First Posted Date

Feb 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2024

Last Update Posted Date

Oct 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexamethasone+Saline	Active Comparator		Drug: Dexamethasone
Dexamethasone+Hyaluronic Acid	Experimental		Drug: Dexamethasone Drug: Hyaluronic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	Dexamethasone 5mg/ml	Dexamethasone+Hyaluronic Acid Dexamethasone+Saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Verification of tympanic membrane with endoscopy (Safety)	Confirming healing time of perforation and inflammation	3-4 weeks after intratympanic injection
Confirmation of inflammation and drug with CT imaging (Durability)	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)	Verifying therapeutic effect of intratympanic drug delivery vehicle	3-4 weeks after intratympanic injection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003639	Hearing Loss, Sudden
D034381	Hearing Loss
D006317	Hearing Loss, Noise-Induced
D008575	Meniere Disease

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone
D006820	Hyaluronic Acid

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided