Intratympanic Steroids for Sudden Hearing Loss | NCT04129697

Studies
Intratympanic Steroids for Sudden Hearing Loss

NCT04129697

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Oct 17, 2019Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Dexamethasone or Methylprednisolone; Sudden Hearing Loss; Intratympanic Steroid

Interventions

Dexamethasone or Methylprednisolone

Countries

Not provided

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

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Estimated

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Oct 15, 2019

First Submission Date that Met QC Criteria

Oct 15, 2019

First Posted Date

Oct 17, 2019Actual

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 15, 2019

Last Update Posted Date

Oct 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

For patients with sudden hearing loss, the initial treatment is not usually effective. We use Dexamethasone or Methylprednisolone to be an Intratympanic steroid administration as a salvage treatment. An randomized, double-blind, multi-center study is designed to find the difference between Dexamethasone or Methylprednisolone.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexamethasone	Active Comparator		Drug: Dexamethasone or Methylprednisolone
Methylprednisolone	Active Comparator		Drug: Dexamethasone or Methylprednisolone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone or Methylprednisolone	Drug	steroids	Dexamethasone Methylprednisolone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hearing	the hearing level after treatment	six month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

sudden hearing loss and initial treatment is not effective

Exclusion Criteria:

the patients refused intratympanic steroids treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The results of the study could be shared with other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003639	Hearing Loss, Sudden

Ancestor Terms

ID	Term
D034381	Hearing Loss
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone
D008775	Methylprednisolone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided