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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038815
Receipt No. 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

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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
Email 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
Email ysktakenaka@gmail.com

Sponsor
Institute Kansai Medical Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044207

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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