UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008249 |
|---|---|
| Receipt number | R000009718 |
| Scientific Title | The effect of Bepotastine besilate OD tablet for Japanese cedar pollinosis in an artificial exposure chamber(OHIO Chamber). |
| Date of disclosure of the study information | 2012/06/26 |
| Last modified on | 2013/01/16 14:40:02 |
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Basic information
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
Condition
Japanese cedar Pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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
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 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
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 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
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
Public contact
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
s-shimizu@trcp.co.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Japan Allergy 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
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 (東京都)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 26 | 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
| 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
Other related information
Management 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
