UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016532 |
|---|---|
| Receipt number | 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 13:42:53 |
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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
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
m.gotoh@nms.ac.jp
Sponsor or person
Institute
Bureau of social welfare and public health, Tokyo Metropolitan Goverment
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019195
