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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032573
Receipt No. R000037145
Scientific Title Effect of betahistine in treating in patients with peripheral vestibular disease
Date of disclosure of the study information 2018/06/01
Last modified on 2018/05/13

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Basic information
Public title Effect of betahistine in treating in patients with peripheral vestibular disease
Acronym Use of betahistine for periperal vertigo
Scientific Title Effect of betahistine in treating in patients with peripheral vestibular disease
Scientific Title:Acronym Use of betahistine for periperal vertigo
Region
Japan

Condition
Condition peripheral vestibular disease
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of betahistine to treat in the patients with peripheral vestibular disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of vertigo
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment of periorally administered betahistine
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with eripheral vestibular disease
Key exclusion criteria Contraindication to use betahistine
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo Shojaku
Organization University of Toyama
Division name Department of Otolaryngology
Zip code
Address 2630 Sugitani, Toyama, Toyama
TEL 0764347368
Email hshojaku@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideo Shojaku
Organization University of Toyama
Division name Department of Otolaryngology
Zip code
Address 2630 Sugitani, Toyama, Toyama
TEL 0764347368
Homepage URL
Email hshojaku@med.u-toyama.ac.jp

Sponsor
Institute University of Toyama
Institute
Department

Funding Source
Organization Self-raising
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 06 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 Open public recruiting
Date of protocol fixation
2015 Year 08 Month 21 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 13 Day
Last modified on
2018 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037145

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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