UMIN-CTR Clinical Trial

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

Japanese cedar and cypress pollinosis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nippon Medical School

Institute

Department

Personal name

Organization

Public Health Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団信濃会 左門町クリニック

Date of disclosure of the study information

2011

Year

05

Month

30

Day

URL releasing protocol

Publication of results

Published

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

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 related 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