UMIN-CTR Clinical Trial

Public title

The effect of Bepotastine besilate OD tablet for Japanese cedar pollinosis in an artificial exposure chamber(OHIO Chamber).

Acronym

The effect of Bepotastine besilate OD tablet for Japanese cedar pollinosis in an artificial exposure chamber(OHIO Chamber).

Scientific Title

The effect of Bepotastine besilate OD tablet for Japanese cedar pollinosis in an artificial exposure chamber(OHIO Chamber).

Scientific Title:Acronym

The effect of Bepotastine besilate OD tablet for Japanese cedar pollinosis in an artificial exposure chamber(OHIO Chamber).

Region

Japan

Condition

Japanese cedar Pollinosis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify effect of Bepotastine besilate OD tablet on nasal symptoms of Japanese cedar pollen exposure in an artifical exposure chamber(OHIO Chamber).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Symptoms score (Nasal)

Key secondary outcomes

1)Nasal secretion volume
2)Number of sneezing
3)Occurrence time of first nasal symptom
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 35 subjects twice daily on the Japanese cedar pollen exposure day(30 minutes after the start of exposure and night).
The next day and the following day, also administered twice daily.

Interventions/Control_2

Placebo tablets administered to 35 subjects twice daily on the Japanese cedar pollen exposure day(30 minutes after the start of exposure and night).
The next day and the following day, also administered 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 over class 2 within the last 3 years.
2)Have experience with cedar pollen exposure in the OHIO Chamber in the past, patients with nasal symptoms.
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 unsuitable for patient enrollment by their doctor (Patients who have undergone nasal operation or patients who have receiving immunotherapy).

Target sample size

70

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	Satoko Shimizu

Organization

Tokyo Reserch Center of Clinical Pharmacology co.,ltd.

Division name

Clinical Trial Operations Support Section,Customer Relations Dept.

Zip code

Address

TEL

Homepage URL

Email

s-shimizu@trcp.co.jp

Institute

Nippon Medical School

Institute

Department

Personal name

Organization

Japan Allergy 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　(東京都)

Date of disclosure of the study information

2012

Year

06

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

2012

Year

06

Month

06

Day

Date of IRB

Anticipated trial start date

2012

Year

07

Month

01

Day

Last follow-up date

2012

Year

07

Month

29

Day

Date of closure to data entry

2012

Year

08

Month

31

Day

Date trial data considered complete

2012

Year

08

Month

31

Day

Date analysis concluded

Other related information

Registered date

2012

Year

06

Month

25

Day

Last modified on

2013

Year

01

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009718