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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006318
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Otorhinolaryngology in Ciba University Graduate School




Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007470

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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