UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022981 |
|---|---|
| Receipt number | 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 | 2021/07/05 18:40:20 |
* 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
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 | Koji |
| Middle name | |
| Last name | Matsumoto |
Organization
Shiga University of Medical Science
Division name
Otorhinolaryngology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
0775482261
matsuk@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Matsumoto |
Organization
Shiga University of Medical Science
Division name
Otorhinolaryngology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2111
Homepage URL
matsuk@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
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
Shiga University of Medical Science
Address
Seta, Tsukinowa-cho, Otsu, Shiga, Japan
Tel
077-548-2261
matsuk@belle.shiga-med.ac.jp
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
| 2021 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026493
