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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022515
Receipt No. 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

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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
Email 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
Email takeda@tokiushima-u.ac.jp

Sponsor
Institute Monistry of Education, Culture, Sports Science and Technology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025955

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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