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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003173
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Suita Municipal Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003847

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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