UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of bepotastine besilate for seasonal allergic rhinitis patients - about laryngeal symptoms, olfactory disorder, sleep disorder, QOL and symptoms caused by Asian sand dust
Acronym	Efficacy of bepotastine besilate for seasonal allergic rhinitis patients
Scientific Title	Efficacy of bepotastine besilate for seasonal allergic rhinitis patients - about laryngeal symptoms, olfactory disorder, sleep disorder, QOL and symptoms caused by Asian sand dust
Scientific Title:Acronym	Efficacy of bepotastine besilate for seasonal allergic rhinitis patients
Region	Japan

Condition
Condition	Seasonal allergic rhinitis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of bepotastine besilate forseasonal allergic rhinitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Nasal symptoms, nasal findings, laryngeal symptoms, laryngeal findings, olfactory disorder, sleep disorder, QOL, and symptoms caused by Asian sand dust
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Bepotastine besilate
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	100 years-old >
Gender	Male
Key inclusion criteria	Seasonal allergic rhinitis patients who come us including related hospitals
Key exclusion criteria	Patients with using any other antiallergic medicine or immunotherapy.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kensei Naito
Organization	Fujita Health University
Division name	Otorhinoralyngology
Zip code
Address	1-98 Denngakugakubo, Kutukake-cho, Toyoake city, Aichi Prefecture
TEL	0562-93-9291
Email	knaito@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomoaki Murashima
Organization	Fujita Health University
Division name	Otorhinoralyngology
Zip code
Address	1-98 Denngakugakubo, Kutukake-cho, Toyoake city, Aichi Prefecture
TEL	0562-93-9291
Homepage URL
Email	abc2-and@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Fujita Health University
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	2014 Year 04 Month 04 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	2013 Year 12 Month 24 Day
Date of IRB	2014 Year 01 Month 15 Day
Anticipated trial start date	2014 Year 01 Month 15 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 04 Month 04 Day
Last modified on	2021 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013512