UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005659
Receipt number R000006687
Scientific Title Efficacy of Bepotastine besilate OD tablets for Japanese cedar and cypress pollinosis in an artificial exposure chamber(OHIO Chamber)
Date of disclosure of the study information 2011/05/30
Last modified on 2011/12/26 14:40:47

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Basic information

Public title

Efficacy of Bepotastine besilate OD tablets for Japanese cedar and cypress pollinosis in an artificial exposure chamber(OHIO Chamber)

Acronym

Efficacy of Bepotastine besilate OD tablets for Japanese cedar and cypress pollinosis in an artificial exposure chamber(OHIO Chamber)

Scientific Title

Efficacy of Bepotastine besilate OD tablets for Japanese cedar and cypress pollinosis in an artificial exposure chamber(OHIO Chamber)

Scientific Title:Acronym

Efficacy of Bepotastine besilate OD tablets for Japanese cedar and cypress pollinosis in an artificial exposure chamber(OHIO Chamber)

Region

Japan


Condition

Condition

Japanese cedar and cypress pollinosis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Many patients with Japanese cedar pollinosis is also positive for cypress pollen.
To investigate the effectiveness of Bepotastine besilate OD tablets in this patients by two consecutive days in a Japanese cedar pollen and cypress pollen.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Symptoms score(Nasal, Ocular, Oropharyngeal)

Key secondary outcomes

1) Occurrence time of the first nasal symptom or the first ocular symptom
2) Nasal secretion volume
3) No of sneezing
4) Digit cancellation test


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Bepotastine besilate OD tablets administered to 14 subjects at twice daily the day before Japanese cedar pollen exposure.
The next day(day of Japanese cedar pollen exposure) also administered twice daily.
In addition the following day(day of cypress pollen exposure) also administerd twice daily.

Interventions/Control_2

Placebo tablets administered to 14 subjects at twice daily the day before Japanese cedar pollen exposure.
The next day(day of Japanese cedar pollen exposure) also administered twice daily.
In addition the following day(day of cypress pollen exposure) also administerd twice daily.

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) CAP-RAST score against Japanese cedar pollen and cypress pollen over 2 within the last 3 years.
2) Patients who have typical seasonal allergic rhinitis symptoms for at least 2 years.
3) Patients who are considered eligible medical examination results investigator doctors.
4) Written informed consent is required.

Key exclusion criteria

1) Some patients with mucosal lesion of the nose and eyes.
2) Patients with severe perennial allergic rhinitis or requiring treatment.
3) Patients who received steroid injections within 6 months.
4) Patients with respiratory disease such as asthma.
5) Patients with past history of anaphylaxis.
6) Patients who have the hypersensitivity to study drug.
7) Pregnancy, breast-feeding woman, potential pregnancy, patients who wish to become pregnant during this study.
8) Patients who were judged to be unsuitabele for patinet enrollment by their doctor(Patients who have undergone nasal operation or patients who have undergone immunotherapy).

Target sample size

28


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kimihiro Okubo

Organization

Nippon Medical School

Division name

Department of Otorhinolaryngology and Head /Neck Surgery

Zip code


Address

1-1-5 Sendagi, Bunkyo-ku Tokyo 113-8603, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kiyochika Suematsu

Organization

Medical Corporation Shinanokai, Samoncho Clinic

Division name

Pharmaceutical Dept.,

Zip code


Address

Yotsuya Medical Bldg., 20, Samon-cho, Shinjuku-ku, Tokyo, 160-0017, Japan

TEL

+81-3-5366-3641

Homepage URL


Email

ki-suematsu@samoncho-clinic.jp


Sponsor or person

Institute

Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

Public Health Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

医療法人社団信濃会 左門町クリニック


Other administrative information

Date of disclosure of the study information

2011 Year 05 Month 30 Day


Related information

URL releasing protocol


Publication of results

Published


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

2011 Year 05 Month 09 Day

Date of IRB


Anticipated trial start date

2011 Year 06 Month 01 Day

Last follow-up date

2011 Year 07 Month 01 Day

Date of closure to data entry

2011 Year 07 Month 01 Day

Date trial data considered complete

2011 Year 07 Month 01 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 05 Month 27 Day

Last modified on

2011 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006687


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name