UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007565 |
|---|---|
| Receipt number | R000008934 |
| Scientific Title | Active comparator stratified randomization study effect oral bepotastine besilate as new treatment for allergic rhinitis. |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2013/09/23 11:41:19 |
* 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
Active comparator stratified randomization study effect oral bepotastine besilate as new treatment for allergic rhinitis.
Acronym
effect of oral bepotastine besilate as new treatment for allergic rhinitis.
Scientific Title
Active comparator stratified randomization study effect oral bepotastine besilate as new treatment for allergic rhinitis.
Scientific Title:Acronym
effect of oral bepotastine besilate as new treatment for allergic rhinitis.
Region
| Japan |
Condition
Condition
seasonal allergic rhinitis
Classification by specialty
| Clinical immunology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the dose effect of oral bepotastine besilate and combination of different characteristic antiallergic medicine with regard to the efficacy as early seasonal treatment for seasonal allergic rhinitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Alteration of nasal symptom and ocular
condition of four weeks and eight weeks after treatment
Key secondary outcomes
Symptom score (stuffy nose,runny nose, sneezing,eye itchiness and tearing), medication score and QOL Questionaire score(JRQLQ No1).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
From the first medical examination, administer 10mg as bepotastine besilate twice a day orally for 2-3 weeks.
Interventions/Control_2
Upon clinical symptoms after first medical treatment, switch to bepotastine besilate 10mg twice a day or combination treatment with anti leukotriene drugs.
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with Japanese cedar or cypress pollinosis
Key exclusion criteria
(1) Patient that change of symptom is remarkable after specific immunotherapy is begun.
(2) Patient who should continuously use medicine (steroid drugs,immunosuppressive drugs and others) that influences when effect of drug evaluation.
(3)Severity dyshepatia and dysnephria patient.
(4) Pregnancy, potential pregnancy, and breast-feeding patient.
(5) the others, inappropriate to this study by the judgment of doctor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato MIwa |
Organization
Juntendo University
Division name
Otorhinolaryngology
Zip code
Address
2-1-1 Hongo,Bunkyo ward,Tokyo,Japan
TEL
81338133111
mmiwa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | masato miwa |
Organization
Juntendo University
Division name
Otorhinolaryngology
Zip code
Address
2-1-1 Hongo,Bunkyo ward,Tokyo,Japan
TEL
81338133111
Homepage URL
mmiwa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
順天堂医院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 23 | Day |
Last modified on
| 2013 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008934
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
