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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016532
Receipt No. R000019195
Scientific Title sublingual immunotherapy for Japanese cedar pollinosis
Date of disclosure of the study information 2015/02/16
Last modified on 2015/02/13

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Basic information
Public title sublingual immunotherapy for Japanese cedar pollinosis
Acronym SLIT for JCP
Scientific Title sublingual immunotherapy for Japanese cedar pollinosis
Scientific Title:Acronym SLIT for JCP
Region
Japan

Condition
Condition Japanese cedar pollinosis
Classification by specialty
Clinical immunology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We evaluate the usefulness of sublingual immunotherapy against cedar pollen allergy patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes symptom medication score, QOL score
Key secondary outcomes Serum cytokines

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Using the standardized cedar pollen extract, sublingual immunotherapy(sublingual-spit) is performed. Gradually increasing the extract, to reach the maintenance dose after one month.
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1,There is rhinitis symptoms in more than three years during cedar pollen season
2,Intradermal test positive or IgE antibody-positive against cedar pollen
3,People who can participate in the test for 3 years in the voluntary
Key exclusion criteria 1,People that have merged with other nose disease
2,People who are using the drug for allergic disease
3,People who have oral steroid
4,People with a history of asthma
5,People who are pregnant
6,People who are breast-feeding
7,People who have serious complications
8,People who doctor has determined unsuitable
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takachika Hiroi
Organization Tokyo Metropolitan Institute of Medical Science
Division name Department of Genome Medicine, Pollen Allergy Project
Zip code
Address kamikitazawa, Setagaya-ku, Tokyo
TEL 03-5316-3126
Email hiroi-tk@igakuken.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Gotoh
Organization Nippon Medical School
Division name otorhinolaryngology
Zip code
Address 1-1-5 sendagi bunkyo-ku, tokyo
TEL 03-3822-2131
Homepage URL
Email m.gotoh@nms.ac.jp

Sponsor
Institute Bureau of social welfare and public health, Tokyo Metropolitan Goverment
Institute
Department

Funding Source
Organization Bureau of social welfare and public health, Tokyo Metropolitan Goverment
Organization
Division
Category of Funding Organization Local Government
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

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 16 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
2006 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 05 Month 01 Day
Last follow-up date
2009 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2009 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 13 Day
Last modified on
2015 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019195

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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