UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003105
Receipt No. R000003766
Scientific Title Clinical efficasy of Montelukast-early-intervention for Japanese cedar pollinosis
Date of disclosure of the study information 2010/01/27
Last modified on 2011/02/22

* 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 Clinical efficasy of Montelukast-early-intervention for Japanese cedar pollinosis
Acronym Clinical efficasy of Montelukast for Japanese cedar pollinosis
Scientific Title Clinical efficasy of Montelukast-early-intervention for Japanese cedar pollinosis
Scientific Title:Acronym Clinical efficasy of Montelukast 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 examimned the efficacy of montelukas-early-intervention for Japanese cedar pollinosis and also looked at the effect of combined therapy using, 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 Effect of leukotriene antagonist
Key secondary outcomes Nitric oxiside consentration in airway

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 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 It is given montelukast 10mg, 1 capsule per 1 day, from a week before until the end of Japanese pollen season.
Interventions/Control_2 It is given montelukast 10mg, 1 capsule per 1 day, from a week before until the end of Japanese pollen season, also and given loratadine 10 mg per 1 day, from peak-season until the end of Japanese pollen season.
Interventions/Control_3 It is given montelukast 10mg, 1 capsule per 1 day, from a week before until the end of Japanese pollen season, also and given a placebo capsule per 1 day, from peak-season until the end of 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 150

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 0776-61-8407
Email

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 23 Matsuoka-Shimoaizuki, Eiheiji, Yoshida, Fukui, Japan
TEL 0776-61-8407
Homepage URL
Email

Sponsor
Institute Faculty of Medicine, University of Fukui
Institute
Department

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 Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2010 Year 01 Month 27 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2010 Year 04 Month 01 Day
Date of closure to data entry
2010 Year 05 Month 01 Day
Date trial data considered complete
2010 Year 10 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 27 Day
Last modified on
2011 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003766

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.