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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028794
Receipt No. R000032954
Scientific Title salvage therapy by amidotrizoate for sudden deafness showing poor response to steroid therapy
Date of disclosure of the study information 2017/09/01
Last modified on 2019/03/12

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Basic information
Public title salvage therapy by amidotrizoate for sudden deafness showing poor response to steroid therapy
Acronym salvage therapy by amidotrizoate for sudden deafness showing poor response to steroid therapy
Scientific Title salvage therapy by amidotrizoate for sudden deafness showing poor response to steroid therapy
Scientific Title:Acronym salvage therapy by amidotrizoate for sudden deafness showing poor response to steroid therapy
Region
Japan

Condition
Condition sudden deafness showing poor response to initial treatment with topical or systemic administration of steroid
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 evaluation of safety and clinical efficacy of amidotrizoate therapy as salvage therapy for sudden deafness showing no response to initial treatment with topical or systemic administration of steroid
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes adverse effect during amidotrizoate therapy
Key secondary outcomes hearing level measured by pure tone audiometry at the end of amidotrizoate therapy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 twenty milliliter of amidotrizoate is slowly administered intravenously once a day during 7 continuous days
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 sudden deafness showing poor response to initial treatment with topical or systemic administration of steroid
Key exclusion criteria 1. old case
2. thyroid disease
3. allergic disorder including bronchial asthma
4. renal dysfunction
5. past history of cerebellovascular disease and/or brain tumor
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tetsuya
Middle name
Last name Tono
Organization University of Miyazaki
Division name Department of otorhinolaryngology, head and neck surgery
Zip code 8891692
Address 5200, kihara, kiyotake, miyazaki, miyazaki, 8891692, Japan
TEL +81-985-85-2966
Email tono@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Nakashima
Organization University of Miyazaki
Division name Department of otorhinolaryngology, head and neck surgery
Zip code 8891692
Address 5200, kihara, kiyotake, miyazaki, miyazaki, 8891692, Japan
TEL +85-985-85-2966
Homepage URL
Email takahiro_nakashima@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

Funding Source
Organization University of Miyazaki
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical research support center
Address 5200, kihara, kiyotake, miyazaki, miyazaki, 8891692, Japan
Tel +81-985-85-9403
Email riken@med.miyazaki-u.ac.jp

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
2017 Year 09 Month 01 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 50
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
2017 Year 04 Month 01 Day
Date of IRB
2015 Year 11 Month 05 Day
Anticipated trial start date
2017 Year 08 Month 28 Day
Last follow-up date
2019 Year 03 Month 22 Day
Date of closure to data entry
2019 Year 03 Month 29 Day
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 23 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032954

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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