UMIN-CTR Clinical Trial

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