UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013625 |
|---|---|
| Receipt number | R000013512 |
| Scientific Title | Efficacy of bepotastine besilate for seasonal allergic rhinitis patients - about laryngeal symptoms, olfactory disorder, sleep disorder, QOL and symptoms caused by Asian sand dust |
| Date of disclosure of the study information | 2014/04/04 |
| Last modified on | 2021/04/16 12:11:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of bepotastine besilate for seasonal allergic rhinitis patients - about laryngeal symptoms, olfactory disorder, sleep disorder, QOL and symptoms caused by Asian sand dust
Acronym
Efficacy of bepotastine besilate for seasonal allergic rhinitis patients
Scientific Title
Efficacy of bepotastine besilate for seasonal allergic rhinitis patients - about laryngeal symptoms, olfactory disorder, sleep disorder, QOL and symptoms caused by Asian sand dust
Scientific Title:Acronym
Efficacy of bepotastine besilate for seasonal allergic rhinitis patients
Region
| Japan |
Condition
Condition
Seasonal allergic rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of bepotastine besilate forseasonal allergic rhinitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nasal symptoms, nasal findings, laryngeal symptoms, laryngeal findings, olfactory disorder, sleep disorder, QOL, and symptoms caused by Asian sand dust
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bepotastine besilate
Interventions/Control_2
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
| 100 | years-old | > |
Gender
Male
Key inclusion criteria
Seasonal allergic rhinitis patients who come us including related hospitals
Key exclusion criteria
Patients with using any other antiallergic medicine or immunotherapy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kensei Naito |
Organization
Fujita Health University
Division name
Otorhinoralyngology
Zip code
Address
1-98 Denngakugakubo, Kutukake-cho, Toyoake city, Aichi Prefecture
TEL
0562-93-9291
knaito@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Murashima |
Organization
Fujita Health University
Division name
Otorhinoralyngology
Zip code
Address
1-98 Denngakugakubo, Kutukake-cho, Toyoake city, Aichi Prefecture
TEL
0562-93-9291
Homepage URL
abc2-and@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 04 | Month | 04 | 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 | 12 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 04 | Day |
Last modified on
| 2021 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013512
