UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003173 |
|---|---|
| Receipt number | R000003847 |
| Scientific Title | Effects of batroxobin on sudden deafness: Hearing outcome and coagulation/fibrinolysis |
| Date of disclosure of the study information | 2010/02/12 |
| Last modified on | 2013/08/12 09:13:00 |
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Basic information
Public title
Effects of batroxobin on sudden deafness: Hearing outcome and coagulation/fibrinolysis
Acronym
Effects of batroxobin on hearing outcome of sudden deafness
Scientific Title
Effects of batroxobin on sudden deafness: Hearing outcome and coagulation/fibrinolysis
Scientific Title:Acronym
Effects of batroxobin on hearing outcome of sudden deafness
Region
| Japan |
Condition
Condition
sudden deafness
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effective mechanisms of batroxobin on hearing improvement of sudden deafness patients by examining the coagulation/fibrinolysis data and hearing outcome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hearing changes and coagulation/fibrinolysis data will be correlated and thus effective mechanisms of batroxobin on sudden deafness could be clarified.
Key secondary outcomes
Prognostic factor of batroxobin on sudden deafness could be found through this study.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
For the patients suffering from sudden deafness, 20BU of batroxobin will be injected for the first day followed by 10BU per 2 days. Final amount of injection will be 110BU of batroxobin.
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 suffering from sudden deafness who accepted the batroxobin injection therapy after hospitalization.
Key exclusion criteria
Patients who do not accept hospitalization. Patients who are not allowed to be injected with batroxobin according to the guidelines for the usage of batroxobin.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Arata Horii |
Organization
Suita Municipal Hospital
Division name
Department of Otolaryngology
Zip code
Address
2-13-20 Katayama-cho, Suita city, Osaka, Japan
TEL
06-6387-3311
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Suita Municipal Hospital
Division name
Department of Otolaryngology
Zip code
Address
TEL
0606387-3311
Homepage URL
Sponsor or person
Institute
Suita Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2010 | Year | 02 | Month | 12 | 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
Completed
Date of protocol fixation
| 2010 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 12 | Day |
Last modified on
| 2013 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003847
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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