UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015278 |
|---|---|
| Receipt number | R000017766 |
| Scientific Title | Epicutaneous and / or intralymphatic immunotherapy for nasal allergy |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2014/10/01 12:56:34 |
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Basic information
Public title
Epicutaneous and / or intralymphatic immunotherapy for nasal allergy
Acronym
Epicutaneous and / or intralymphatic immunotherapy
Scientific Title
Epicutaneous and / or intralymphatic immunotherapy for nasal allergy
Scientific Title:Acronym
Epicutaneous and / or intralymphatic immunotherapy
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the efficacy and safty for Epicutaneous and / or intralymphatic immunotherapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
nasal symptom score during the pollen season
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intralymphatic
total12week, 2 JAU 0.02ml/w x 3 times
Interventions/Control_2
epicutaneous
total4week, 2000 JAU 0.2ml/w x 4 times
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Japanese cedar pollinosis
Key exclusion criteria
asthma
under immunotherapy
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kawata Ryo |
Organization
Osaka Medical College
Division name
Otorhinolaryngology
Zip code
Address
2-7 Daigaku-cho Takatsuki City Osaka
TEL
072-683-1221
oto034@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Terada Tetsuya |
Organization
Osaka Medical College
Division name
Otorhinolaryngology
Zip code
Address
2-7 Daigaku-cho Takatsuki City Osaka
TEL
072-683-1221
Homepage URL
oto056@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College Otorhinolaryngology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | 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
| 2014 | Year | 09 | Month | 29 | Day |
Last modified on
| 2014 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017766
