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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008127
Receipt No. R000009241
Scientific Title Intratympanic injection of Edaravone for idiopathic sudden sensorineural hearing loss
Date of disclosure of the study information 2012/06/11
Last modified on 2018/03/07

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Basic information
Public title Intratympanic injection of Edaravone for idiopathic sudden sensorineural hearing loss
Acronym Intratympanic Edaravone therapy for ISSHL
Scientific Title Intratympanic injection of Edaravone for idiopathic sudden sensorineural hearing loss
Scientific Title:Acronym Intratympanic Edaravone therapy for ISSHL
Region
Japan

Condition
Condition idiopathic sudden sensorineural hearing loss
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To improve the outcome in the patients with profound hearing loss
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes five frequencies average hearing level in pure tone audiogram
Key secondary outcomes

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 edaravone injection
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) within three days from the onset
2) average hearing level >= 90dB
Key exclusion criteria 1) patients with serious general complication
2) patients with anaphylaxis aganst edaravone
3) woman with pregnancy/lactation
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Sano
Organization Kitasato University
Division name department of Otorhinolaryngology
Zip code
Address 1-15-1 Kitasato Minamiku Sagamihara Kanagawa
TEL 042-778-8111
Email sanohj@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Sano
Organization Kitasato University Hospital
Division name Department of Otorhinolaryngology
Zip code
Address 1-15-1 Kitasato Minamiku Sagamihara Kanagawa
TEL 042-778-8466
Homepage URL
Email sanohj@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato University Hospital
Institute
Department

Funding Source
Organization Kitasato University 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
Address
Tel
Email

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
2012 Year 06 Month 11 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 No longer recruiting
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2015 Year 12 Month 01 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 06 Month 08 Day
Last modified on
2018 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009241

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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