UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011336 |
|---|---|
| Receipt number | R000013187 |
| Scientific Title | Effect of add-on medication (with dose increase, combined with anti-leukotriene , combined with steroid nasal spray)for allergic rhinitis patients who are not effective of normal dose of Bepotastine besilate . |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2016/08/04 14:58:51 |
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Basic information
Public title
Effect of add-on medication (with dose increase, combined with anti-leukotriene ,
combined with steroid nasal spray)for allergic rhinitis patients who are not effective of normal dose of Bepotastine besilate .
Acronym
Effect of add-on medication (with dose increase, combined with anti-leukotriene ,
combined with steroid nasal spray)for allergic rhinitis patients who are not effective of normal dose of Bepotastine besilate .
Scientific Title
Effect of add-on medication (with dose increase, combined with anti-leukotriene ,
combined with steroid nasal spray)for allergic rhinitis patients who are not effective of normal dose of Bepotastine besilate .
Scientific Title:Acronym
Effect of add-on medication (with dose increase, combined with anti-leukotriene ,
combined with steroid nasal spray)for allergic rhinitis patients who are not effective of normal dose of Bepotastine besilate .
Region
| Japan |
Condition
Condition
allergic rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the effect of add-on medication (with dose increase,combined with anti-leukotriene,combined with steroid nasal spray) for allergic patients
.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Assesment of symptom after as below for the allergic rhinitis patients .
Allergic rhinitis patients are separeted 3groups(dose increase,combined with anti-luekotriene, combined with steroid nasal spray) ,and carry on for 4 week.
Assesment:medical examination at the department of otorhinolaryngology with a disease questionnaire.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1Double dose , 2used together with anti leuotorien,3used together with steroid nasal spray
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
allergoc rhinitis
Key exclusion criteria
Patients judged inappropriate for this study by the physicians
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nibu Keni-chi |
Organization
Kobe University Graduate Scool of Medicine
Division name
Department of otorhinolaryngology Head and Neck Surgery
Zip code
Address
7-5-1,Kusunoki-cho,Chuo-ku,Kobe,Hyogo,650-0017,Japan
TEL
81-78-382-5111
nibu@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nibu Keni-chi |
Organization
Kobe University Graduate Scool of Medicine
Division name
Department of otorhinolaryngology Head and Neck Surgery
Zip code
Address
7-5-1,Kusunoki-cho,Chuo-ku,Kobe,Hyogo,650-0017,Japan
TEL
81-78-382-5111
Homepage URL
http://www.hosp.kobe-u.ac.jp/chiken/OOchiken_top.htm
nibu@med.kobe-u.ac.jp
Sponsor or person
Institute
Graduate Scool of Medicine
Institute
Department
Personal name
Funding Source
Organization
Graduate Scool of Medicine Department of otorhinolaryngology Head and Neck Surgery
Organization
Division
Category of Funding Organization
Other
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 | 10 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 31 | Day |
Last modified on
| 2016 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013187
