UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036469 |
|---|---|
| Receipt number | R000041484 |
| Scientific Title | Efficacy and Safety of Sequential Sublingual Immunotherapy with Japanese Ceder Pollen and House Dust Mite allergens |
| Date of disclosure of the study information | 2019/04/11 |
| Last modified on | 2019/04/10 19:49:04 |
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Basic information
Public title
Efficacy and Safety of Sequential Sublingual Immunotherapy with Japanese Ceder Pollen and House Dust Mite allergens
Acronym
Efficacy and Safety of Sequential SLIT with JCP and HDM
Scientific Title
Efficacy and Safety of Sequential Sublingual Immunotherapy with Japanese Ceder Pollen and House Dust Mite allergens
Scientific Title:Acronym
Efficacy and Safety of Sequential SLIT with JCP and HDM
Region
| Japan |
Condition
Condition
allergic rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of efficacy and safety of sequential Sublingual Immunotherapy with Japanese Ceder Pollen and House Dust Mite allergens
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examination of side effects:Evaluate about the presence of local reaction and systemic reaction at the medical examination.
Key secondary outcomes
Examination of efficacy:symptom-medication score, QOL, VAS scale
Base
Study type
Observational
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
| 5 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese ceder pollen and house dust mite allergic rhinitis
Key exclusion criteria
Patients who can not obtain written research cooperation.
Patients who can not confirm their own consent to participate in research.
Patients who are judged not to participate in this study by their doctor
Target sample size
184
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Kohzaki |
Organization
Shiga University of Medical Science
Division name
otorhinolaryngology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
0775482111
hkohzaki@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Kohzaki |
Organization
Shiga University of Medical Science
Division name
otorhinolaryngology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
0775482111
Homepage URL
hkohzaki@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Self funding
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
0775482111
hkohzaki@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
| 2019 | Year | 04 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the efficacy and safety of sequential sublingual immunotherapy with Japanese Ceder Pollen and House Dust Mite allergens as compared with single sublingual immunotherapy with Japanese Ceder Pollen or House Dust Mite.
Management information
Registered date
| 2019 | Year | 04 | Month | 10 | Day |
Last modified on
| 2019 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041484
