UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006318 |
|---|---|
| Receipt number | R000007470 |
| Scientific Title | A randomized controlled trial for the prevention of Japanese cedar pollinosis by Levocetirizine in the pollen exposure chamber |
| Date of disclosure of the study information | 2011/09/09 |
| Last modified on | 2012/09/18 23:40:48 |
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Basic information
Public title
A randomized controlled trial for the prevention of Japanese cedar pollinosis by Levocetirizine in the pollen exposure chamber
Acronym
A randomized controlled trial for the prevention of Japanese cedar pollinosis by Levocetirizine in the pollen exposure chamber
Scientific Title
A randomized controlled trial for the prevention of Japanese cedar pollinosis by Levocetirizine in the pollen exposure chamber
Scientific Title:Acronym
A randomized controlled trial for the prevention of Japanese cedar pollinosis by Levocetirizine in the pollen exposure chamber
Region
| Japan |
Condition
Condition
cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of prophylactic treatmentof Levocetirizine for cedar pollinosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total nasal symptom score in Day1 (3hr of pollen exposition).
Key secondary outcomes
1.A symptom in a chamber in Day1.
2.A symprom after pollen exposition in Day1.
3.Nasal nitric oxide before and after pollen exposition.
4.Safty.
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
YES
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The first day of pollen exposition (1hr) is defined Day0. The second day of pollen exposition (3hr) is defined Day1. 7days berore pollen exposition are defined as Day-7 - Day-1. Group A takes Levocetirizine 5mg from Day-7 to Day 0.
Interventions/Control_2
The first day of pollen exposition (1hr) is defined Day0. The second day of pollen exposition (3hr) is defined Day1. 7days berore pollen exposition are defined as Day-7 - Day-1. Group B takes placebo from Day-7 to Day-1 and Levocetirizine 5mg on Day0.
Interventions/Control_3
The first day of pollen exposition (1hr) is defined Day0. The second day of pollen exposition (3hr) is defined Day1. 7days berore pollen exposition are defined as Day-7 - Day-1. Group A takes placebo from Day-7 to Day 0.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients who have medical history of cedar pollinosis for more than 2 years.
2)Positive specific IgE to cry j1/2 antigen(CAP-RAST>=class2)
3)Patients who develop clear symptoms by a pollen exposure for 3 hours.
Key exclusion criteria
1)Pregnant women and those at risk of pregnancy
2)lactating woman
3)Complication of the other nasal-paranasal disease
4)Use of other antiallergic agent
5)Allergia for an ingredient of Levocetirizine
6)severe renal disturbance (creatinine clearance: less than 10mL/min)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Okamoto |
Organization
Chiba University Graduate School
Division name
Department of Otorhinolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL
043-222-7171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Syuji Yonekura |
Organization
Chiba University Graduate School
Division name
Department of Otorhinolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL
043-222-7171
Homepage URL
Sponsor or person
Institute
Department of Otorhinolaryngology in Ciba University Graduate School
Institute
Department
Personal name
Funding Source
Organization
CLinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization
Non profit foundation
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
千葉大学大学院医学研究院 耳鼻咽喉科
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 09 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 09 | Day |
Last modified on
| 2012 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007470
