UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013625
Receipt number R000013512
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
Date of disclosure of the study information 2014/04/04
Last modified on 2021/04/16 12:11:36

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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 or person

Institute

Fujita Health University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013512


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name