UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002338 |
|---|---|
| Receipt number | R000002864 |
| Scientific Title | Effect of single-drug treatment on acute low-tone sensorineural hearing loss |
| Date of disclosure of the study information | 2009/08/15 |
| Last modified on | 2010/02/15 07:39:38 |
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Basic information
Public title
Effect of single-drug treatment on acute low-tone sensorineural hearing loss
Acronym
single-drug treatment on ALHL
Scientific Title
Effect of single-drug treatment on acute low-tone sensorineural hearing loss
Scientific Title:Acronym
single-drug treatment on ALHL
Region
| Japan |
Condition
Condition
acute low-tone sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of the effect of single-drug treatment on the acute low-tone sensorineural hearing loss
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recovery of the hearing after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
prednisolone
Interventions/Control_2
isosorbide
Interventions/Control_3
ATP
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 1 week from the onset
2) without previous treatment
3) without any past history of acute hearing loss
4) the sum of the hearing level at 125, 250, 500 Hz is more than 70dB
5) the sum of the hearing level at 2, 4, 8 kHz is less than 60dB
Key exclusion criteria
patients who do not fit to the above condition
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaoru Ogawa |
Organization
School of medicine, Keio university
Division name
Department of otorhinolaryngology,
Zip code
Address
Shinanomachi 35 Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of medicine, Keio university
Division name
Shinanomachi 35 Shinjuku-ku, Tokyo
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 14 | Day |
Last modified on
| 2010 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002864
| 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 |
