UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010454 |
|---|---|
| Receipt number | R000012196 |
| Scientific Title | The efficacy of intratympanic steroid injection for sudden sensorineural hearing loss |
| Date of disclosure of the study information | 2013/04/09 |
| Last modified on | 2018/08/08 09:15:49 |
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Basic information
Public title
The efficacy of intratympanic steroid injection for sudden sensorineural hearing loss
Acronym
The efficacy of intratympanic steroid injection for sudden sensorineural hearing loss
Scientific Title
The efficacy of intratympanic steroid injection for sudden sensorineural hearing loss
Scientific Title:Acronym
The efficacy of intratympanic steroid injection for sudden sensorineural hearing loss
Region
| Japan |
Condition
Condition
sudden sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety of intratympanic steroid injection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pure-tone average
hearing recovery rate
Key secondary outcomes
speech discrimination sccore
DPOAE level
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
intratympanic steroid injection
Interventions/Control_2
contorol
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with sudden sensorineural hearing loss
Key exclusion criteria
Hypertension and diabetes in a noncompensated status, history of
ischemic disorders (stroke, heart attack), Meniere's disease, retrocochlear diseases, trauma, radiation-induced HL, or any other identifiable etiology responsible or triggering sudden HL
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Kurono |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Dept. of Otolaryngology-Head and Neck Surgery
Zip code
Address
8-35-1, Sakuragaoka, Kagoshima, 890-8520, JAPAN
TEL
099-275-5410
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Dept. of Otolaryngology-Head and Neck Surgery
Zip code
Address
TEL
099-275-5410
Homepage URL
Sponsor or person
Institute
Dept. of Otolaryngology-Head and Neck Surgery
Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Dept. of Otolaryngology-Head and Neck Surgery
Kagoshima University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
鹿児島大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 09 | Day |
Last modified on
| 2018 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012196
