UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001362 |
|---|---|
| Receipt number | R000001659 |
| Scientific Title | Clinical effect of luekotriene receptor antagonist on provocation symptom induced by Japanese cedar pollene antigen disc and grope for clinical marker of nasal obstraction |
| Date of disclosure of the study information | 2008/10/01 |
| Last modified on | 2009/03/09 15:18:35 |
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Basic information
Public title
Clinical effect of luekotriene receptor antagonist on provocation symptom induced by Japanese cedar pollene antigen disc and grope for clinical marker of nasal obstraction
Acronym
Clinical effect of luekotriene receptor antagonist for Japanese cedar pollinosis
Scientific Title
Clinical effect of luekotriene receptor antagonist on provocation symptom induced by Japanese cedar pollene antigen disc and grope for clinical marker of nasal obstraction
Scientific Title:Acronym
Clinical effect of luekotriene receptor antagonist for Japanese cedar pollinosis
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine effect of leukotriene receptor antagonist for Japanese cedar pollinosis using a randomized, double-blined, placebo-controlled study. We measure Nicotid Oxide concentration in patient's nasal cavity and the value of Oxidative stress substances to assess the correlation of nasal obstraction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Effect of leukotriene receptor antagonist
Key secondary outcomes
Serum and urinary oxidized stress substances concentration. Nicotid Oxide concentration in nasal cavity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
It is given the test capsule containing leukotriene receptor antagonist(montelukast Na 10mg): 1 capsule per 1 day for a week before the Japanese cedar pollene provocation test.
Interventions/Control_2
It is given the placebo capsule containing lactatose powder: 1 capsule per 1 day for a week before the Japanese cedar pollene provocation test.
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
CAP-RAST against Japanese cedar pollen over class 2 whith clinical history of allergic symptoms during the Japanese cedar pollen season.
Key exclusion criteria
Pregnancy, potential pregnancy, and breast-feeding patient.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeharu Fujieda |
Organization
Faculity of Medicine, University of Fukui
Division name
Dep. of Otorhinolaryngology-Head and Neck Surgery
Zip code
Address
23 Matsuokashimoaiduki, Eiheiji-Cho, Yoshida-gun, Fukui Prefecture
TEL
0776-61-3111(ext.2398)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Youko Osawa |
Organization
Faculity of Medicine, University of Fukui
Division name
Dep. of Otorhinolaryngology-Head and Neck Surgery
Zip code
Address
23 Matsuokashimoaiduki, Eiheiji-Cho, Yoshida-gun, Fukui Prefecture
TEL
0776-61-3111(ext.2398)
Homepage URL
fukuoka@u-fukui.ac.jp
Sponsor or person
Institute
Faculity of Medicine, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Dep. of Otorhinolaryngology-Head and Neck Surgery, Faculity of Medicine, University of Fukui
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
Other administrative information
Date of disclosure of the study information
| 2008 | 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
Completed
Date of protocol fixation
| 2008 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 09 | Day |
Last modified on
| 2009 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001659
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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