UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022515 |
|---|---|
| Receipt number | R000025955 |
| Scientific Title | Efficacy of acute treatment with steroid in patients with vestibular neuritis |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2019/12/02 20:48:57 |
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Basic information
Public title
Efficacy of acute treatment with steroid in patients with vestibular neuritis
Acronym
Efficacy of acute treatment with steroid in patients with vestibular neuritis
Scientific Title
Efficacy of acute treatment with steroid in patients with vestibular neuritis
Scientific Title:Acronym
Efficacy of acute treatment with steroid in patients with vestibular neuritis
Region
| Japan |
Condition
Condition
vestibular neuritis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the present study, an attempt is made to clarify the efficacy of acute treatment with steroid in patients with vestibular neuritis. For this purpose, we administrated prednisolone orally at tapering doses from 60 mg for 9 days within a month of the onset of vestibular neuritis. We then examined changes in DHI scores and canal paresis percentages in caloric test up to 12 months after the onset.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DHI scores and canal paresis percentages in caloric test
Key secondary outcomes
Spontaneous, positional and positioning nystagmus, hearing levels, and findings of VEMP (vestibular myogenic myogenic potential) and vHIT (video Head Impulse Test).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration with prednisolone at tapering doses from 60 mg for 9 days within a month of the onset of vestibular neuritis
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult patients at ages fron 20 to 80 years old, who suffered from vestibular neuritis, but not Meniere's disease and benign paroxysmal positional vertigo, within a month of the onset
Key exclusion criteria
1) Patients who suffered from episodic vertigo
2) Patients who was excluded by investigators
3) Patients who suffered from infectious disease refractory to antibacterial drugs
4) Patients who suffered from peptic ulcer
5) Patients who suffered from psychological disease
6) Patients who suffered from tuberculosis
7) Patients who suffered from corneitis due to HSV
8) Patients who suffered from cataracta
9) Patients who suffered from glaucoma
10) Patients who suffered from hypertension
11) Patients who suffered from electrolyte abnormality
12) Patients who suffered from thrombosis
13) Patients who suffered after recent visceral operation
14) Patients who suffered from acute cardiac infarction
15) Patients who suffered from prednisolone intolerance
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki Takeda |
Organization
University of Tokushima School of Medicine
Division name
Department of Otolaryngology
Zip code
Address
3-18-15 Kuramoto, Tokushima, Japan
TEL
088-633-7169
takeda@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriaki Takeda |
Organization
University of Tokushima School of Medicine
Division name
Department of Otolaryngology
Zip code
Address
3-18-15 Kuramoto, Tokushima, Japan
TEL
088-633-7169
Homepage URL
takeda@tokiushima-u.ac.jp
Sponsor or person
Institute
Monistry of Education, Culture, Sports Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency of Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 07 | 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
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
| 2016 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 29 | Day |
Last modified on
| 2019 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025955
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| Registered date | File name |
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