UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005121 |
|---|---|
| Receipt number | R000006088 |
| Scientific Title | The combined therapy of Montelukast plus H1-antihistamine for for moderate to severe Japanese cedar pollinosis and its clinical efficasy |
| Date of disclosure of the study information | 2011/02/22 |
| Last modified on | 2011/09/05 13:39:55 |
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Basic information
Public title
The combined therapy of Montelukast plus H1-antihistamine for for moderate to severe Japanese cedar pollinosis and its clinical efficasy
Acronym
The combined therapy of Montelukast plus H1-antihistamine tion for for for Japanese cedar pollinosis and its clinical efficasy
Scientific Title
The combined therapy of Montelukast plus H1-antihistamine for for moderate to severe Japanese cedar pollinosis and its clinical efficasy
Scientific Title:Acronym
The combined therapy of Montelukast plus H1-antihistamine tion for for for Japanese cedar pollinosis and its clinical efficasy
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examimned the efficacy of combined therapy using Montelukast and H1-antihistamine for moderate to severe Japanese cedar pollinosis with, a randomized, double-blined, placebo-controlled study during pollen-season.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
The combined therapy of Montelukast plus H1-antihistamine
Key secondary outcomes
Nitric oxide consentration in upper airway
Base
Study type
Interventional
Study design
Basic design
Parallel
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
It is given montelukast 10mg plus loratadine 10 mg per 1 day, during Japanese pollen season.
Interventions/Control_2
It is given montelukast 10mg plus placebo per 1 day, during Japanese pollen season.
Interventions/Control_3
It is given montelukast 10mg plus placebo per 1 day, during Japanese pollen season.
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
Being over class 2 in CAP-RAST against Japanese Cedar pollen over, and having clinicalsymptoms during Japanese cedar pollen season.
Key exclusion criteria
Pregnancy, potential pregnancy, and breas-feeding patient.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeharu Fujieda |
Organization
Faculty of Medicine, University of Fukui
Division name
Ororhinolaryngology, Head and Neck Surgery
Zip code
Address
23 Matsuoka-Shimoaizuki, Eiheiji, Yoshida, Fukui, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takechiyo Yamada |
Organization
Faculty of Medicine, University of Fukui
Division name
Ororhinolaryngology, Head and Neck Surgery
Zip code
Address
TEL
Homepage URL
ymdtkcy@gmail.com
Sponsor or person
Institute
Faculty of Medicine, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Ororhinolaryngology, Head and Neck Surgery, Faculty of Medicine, University of Fukui
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
| 2011 | Year | 02 | Month | 22 | 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
| 2011 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 22 | Day |
Last modified on
| 2011 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006088
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
