UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010687 |
|---|---|
| Receipt number | R000012491 |
| Scientific Title | A clnical study to assess inhibitory effect of bepotastine besilate OD tablet to compare with fexofenadine hydrochloride and pseudoephedrine hydrochloride combination tablet in patients with cedar pollinosis in the OHIO Chamber. |
| Date of disclosure of the study information | 2013/05/25 |
| Last modified on | 2013/11/10 13:53:14 |
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Basic information
Public title
A clnical study to assess inhibitory effect of bepotastine besilate OD tablet to compare with fexofenadine hydrochloride and pseudoephedrine hydrochloride combination tablet in patients with cedar pollinosis in the OHIO Chamber.
Acronym
A clnical study to assess inhibitory effect of bepotastine besilate OD tablet to compare with fexofenadine hydrochloride and pseudoephedrine hydrochloride combination tablet in patients with cedar pollinosis in the OHIO Chamber.
Scientific Title
A clnical study to assess inhibitory effect of bepotastine besilate OD tablet to compare with fexofenadine hydrochloride and pseudoephedrine hydrochloride combination tablet in patients with cedar pollinosis in the OHIO Chamber.
Scientific Title:Acronym
A clnical study to assess inhibitory effect of bepotastine besilate OD tablet to compare with fexofenadine hydrochloride and pseudoephedrine hydrochloride combination tablet in patients with cedar pollinosis in the 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
A clnical study to assess inhibitory effect of bepotastine besilate OD tablet to compare with fexofenadine hydrochloride and pseudoephedrine hydrochloride combination tablet in patients with cedar pollinosis in the OHIO Chamber.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective symptoms
Key secondary outcomes
Nasal secretion volume
Number of sneezing
Exercise-based treatment programs
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Term I: placebo
Interventions/Control_2
Term II: test drug or reference drug
Interventions/Control_3
Term III: reference drug or test drug
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
CAPRAST score against Japanese cedar pollen from 2 to 6 within the last 2 years.
Patient whom the nose symptom that was apparent to the cedar pollen scattering period past 2 years developed in.
Key exclusion criteria
1)Patients with mucosal lesion of the nose and eyes.
2)Patients with severe or requiring treatment needed Allergic Rhinitis.
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 anaphylaxis with these drugs.
7)Patients with pregnancy, delivery or lactation.
Target sample size
56
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
TEL
03-3822-2131
ent-kimi@nms.ac.jp
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
Customer Relations Dept.
Zip code
Address
20, Samon-cho, Shinjyuku-ku, Tokyo
TEL
03-5366-3454
Homepage URL
s-shimizu@trcp.co.jp
Sponsor or person
Institute
Samoncho Clinic
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 25 | 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 | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 10 | Day |
Last modified on
| 2013 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012491
