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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022981
Receipt No. R000026493
Scientific Title Effect of the Toll like receptor 4 agonist(GLA: Glucopyranosyl Lipid A) for Japanese cedar pollinosis.
Date of disclosure of the study information 2016/07/01
Last modified on 2019/07/05

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Basic information
Public title Effect of the Toll like receptor 4 agonist(GLA: Glucopyranosyl Lipid A) for Japanese cedar pollinosis.
Acronym Effect of the Toll like receptor 4 agonist(GLA: Glucopyranosyl Lipid A) for Japanese cedar pollinosis.
Scientific Title Effect of the Toll like receptor 4 agonist(GLA: Glucopyranosyl Lipid A) for Japanese cedar pollinosis.
Scientific Title:Acronym Effect of the Toll like receptor 4 agonist(GLA: Glucopyranosyl Lipid A) for Japanese cedar pollinosis.
Region
Japan

Condition
Condition Japanese cedar pollinosis
Classification by specialty
Oto-rhino-laryngology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To make new therapeutic medicine for Japanese cedar pollinosis.
Basic objectives2 Others
Basic objectives -Others To evaluate the effect of GLA to inhibit Th2 immune response.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Secretion of Th2 cytokines from PBMC.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
12 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with nasal or sinus disease.
Key exclusion criteria people who can't show self-determination
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Matsumoto
Organization Shiga University of Medical Science
Division name Otorhinolaryngology
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga
TEL 077-548-2111
Email matsuk@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Matsumoto
Organization Shiga University of Medical Science
Division name Otorhinolaryngology
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga
TEL 077-548-2111
Homepage URL
Email matsuk@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Immune Design Corp.
Organization
Division
Category of Funding Organization Outside Japan
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
2016 Year 07 Month 01 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 Enrolling by invitation
Date of protocol fixation
2016 Year 05 Month 10 Day
Date of IRB
2016 Year 04 Month 26 Day
Anticipated trial start date
2016 Year 05 Month 10 Day
Last follow-up date
2019 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information collection of blood

Management information
Registered date
2016 Year 07 Month 01 Day
Last modified on
2019 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026493

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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