UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028794 |
|---|---|
| Receipt number | 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 19:01:48 |
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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
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
takahiro_nakashima@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
