UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004515 |
|---|---|
| Receipt number | R000005402 |
| Scientific Title | The evaluation of the diagnostic methods and the diagnostic criteria of the steroid dependent sensorineural hearing loss |
| Date of disclosure of the study information | 2010/11/08 |
| Last modified on | 2012/05/08 16:35:54 |
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Basic information
Public title
The evaluation of the diagnostic methods and the diagnostic criteria of the steroid dependent sensorineural hearing loss
Acronym
The evaluation of the steroid dependent sensorineural hearing loss
Scientific Title
The evaluation of the diagnostic methods and the diagnostic criteria of the steroid dependent sensorineural hearing loss
Scientific Title:Acronym
The evaluation of the steroid dependent sensorineural hearing loss
Region
| Japan |
Condition
Condition
steroid dependent sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to determine a new diagnostic method and diagnostic criteria of the steroid dependent sensorineural hearing loss
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The clinical course of the patients, and the blood tests
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who was diagnosed as the steroid dependent sensorineural hearing loss
Key exclusion criteria
no
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Inoue |
Organization
Keio university
Division name
school of medicine
Zip code
Address
shinanomachi 35 shinnjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Inoue |
Organization
keio university school of medicine
Division name
Department of ORL
Zip code
Address
TEL
Homepage URL
yas712@sc.itc.keio.ac.jp
Sponsor or person
Institute
Keio university
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
Organization
Division
Category of Funding Organization
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
慶應義塾大学病院（東京都）、東京医科歯科大学病院（東京都）、杏林大学病院（東京都）、日野市立病院（東京都）、防衛医科大学病院（埼玉県）、岩手医科大学病院（岩手県）、北里大学病院（神奈川県）、岡山大学病院（岡山県）、福岡大学病院（福岡県）、国立成育医療研究センター（東京都）、名古屋大学病院（愛知県）、神戸大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 07 | Month | 01 | Day |
Other
Other related information
In this trial,we could find no objective item in order to diagnose the steroid dependent sensorineural hearing loss.
However, we could establish new diagnostic criteria of the disease.
Management information
Registered date
| 2010 | Year | 11 | Month | 08 | Day |
Last modified on
| 2012 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005402
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
