UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038815 |
|---|---|
| Receipt number | R000044207 |
| Scientific Title | Intratympanic steroid injection for sudden sesorineural hearing loss: a prospective observational study |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2020/11/11 17:10:09 |
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Basic information
Public title
middel ear injection of steroid for sudden deafness
Acronym
middle ear injection of steroid
Scientific Title
Intratympanic steroid injection for sudden sesorineural hearing loss: a prospective observational study
Scientific Title:Acronym
Intratympanic steroid injection for sudden sesorineural 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
The standard 1st line therapy for sudden deafness is systemic administration of steroids. In many countries, patinets ineligible for systemic steroids and those who do not recover after systemic steroid therapy recieve intratympanic steroid injection.However, the intratympanic injection is not allowed in the healthcare systme of Japan. The objective of this study is to investigate prospectively the efficacy and adverse events of intratympanic steroid injection among Japanese patients with sudden deafness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement in pure tone audiometry at the end of the therapy, one month after the treatment, and 3months after the treatment
Key secondary outcomes
adverse events, such as tympanic membrane perforation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intratympanic injection of steroids
dexamethasone 5mg/ml
one administration per week.Total of 4 administrations
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1,age above 20
2,infomed consent by written documents
3,within 6 weeks from the onset
4, hearing loss of grade 3 or 4
ineligible for systemic steroids
or
unrecovered after systemic steroids
Key exclusion criteria
1, history of allergy to dexamethasone
2, history of allergy to EMLA cream
3, active infection in the middele ear
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | yukinori |
| Middle name | |
| Last name | takenaka |
Organization
Kansai medical hospital
Division name
department of otolaryngology
Zip code
5600083
Address
1 Chome-1-7-2 Shinsenri Nishimachi, Toyonaka, Osaka
TEL
0668361199
ysktakenaka@gmail.com
Public contact
Name of contact person
| 1st name | yukinori |
| Middle name | |
| Last name | takenaka |
Organization
Kansai medical hospital
Division name
department of otolaryngology
Zip code
5600083
Address
1 Chome-1-7-2 Shinsenri Nishimachi, Toyonaka, Osaka
TEL
0668361199
Homepage URL
ysktakenaka@gmail.com
Sponsor or person
Institute
Kansai Medical Hospital
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical Hospital
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
kansai medical hospital
Address
1 Chome-1-7-2 Shinsenri Nishimachi, Toyonaka, Osaka
Tel
0668361199
takenaka@kansaimecidal-hp.jp
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 06 | Day |
Last modified on
| 2020 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044207
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
