Back to resultsIntratympanic Steroids for Sudden Hearing Loss
Primary Purpose
Dexamethasone or Methylprednisolone; Sudden Hearing Loss; Intratympanic Steroid
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexamethasone or Methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Dexamethasone or Methylprednisolone; Sudden Hearing Loss; Intratympanic Steroid
Eligibility Criteria
Inclusion Criteria:
sudden hearing loss and initial treatment is not effective
Exclusion Criteria:
the patients refused intratympanic steroids treatment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dexamethasone
Methylprednisolone
Arm Description
Outcomes
Primary Outcome Measures
hearing
the hearing level after treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT04129697
First Posted
October 15, 2019
Last Updated
October 15, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04129697
Brief Title
Intratympanic Steroids for Sudden Hearing Loss
Official Title
Intratympanic Dexamethasone or Methylprednisolone for Sudden Hearing Loss as a Salvage Treatment: a Randomized, Double-blind, Multi-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexamethasone or Methylprednisolone; Sudden Hearing Loss; Intratympanic Steroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Title
Methylprednisolone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexamethasone or Methylprednisolone
Intervention Description
steroids
Primary Outcome Measure Information:
Title
hearing
Description
the hearing level after treatment
Time Frame
six month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
sudden hearing loss and initial treatment is not effective
Exclusion Criteria:
the patients refused intratympanic steroids treatment.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The results of the study could be shared with other researchers
Learn more about this trial
Intratympanic Steroids for Sudden Hearing Loss
We'll reach out to this number within 24 hrs