UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024129 |
|---|---|
| Receipt number | R000027760 |
| Scientific Title | Sequential Treatment Initiation with Japanese Cedar droplet and HDM tablet Sublingual Immunotherapy Followed by Simultaneous Treatment |
| Date of disclosure of the study information | 2016/09/25 |
| Last modified on | 2018/12/20 09:29:10 |
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Basic information
Public title
Sequential Treatment Initiation with Japanese Cedar droplet and HDM tablet Sublingual Immunotherapy Followed by Simultaneous Treatment
Acronym
STJc&M Study
Scientific Title
Sequential Treatment Initiation with Japanese Cedar droplet and HDM tablet Sublingual Immunotherapy Followed by Simultaneous Treatment
Scientific Title:Acronym
STJc&M Study
Region
| Japan |
Condition
Condition
Allergic Rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety study of sequential treatment initiation with Japanese Cedar droplet and HDM tablet Sublingual Immunotherapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Evaluation of adverse events in CTCAE v4.0 and Grading system for SLIT local AEs
Key secondary outcomes
Symptom score,VAS, QOL Questionaire score(RQLQ,JRQLQ), Change of Biomarkers in blood
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
Patients are received Japanese Cedar droplet from October 2016. Patients are received HDM tablet from November 2016. The dosing inerval is 5 minutes.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)A history of Japanese cedar pollinosis and House dust mite allergic rhinitis before study entry.
(2)Anti-Japanese ceder pollen IgE antibodyand Anti-House dust mite IgE antibody are positive
(3)Positive house dust mite allergen provocation test
(4)Written informed consent is required
Key exclusion criteria
(1)Received Japanese cedar pollen or house dust mite aleergen immunotherapy
(2)Taking any immunosuppressive drugs or any anticancer drugs
(3)Patients with upper respiratory inflammation, respiratory infection, or severe bronchial asthma
(4)Patients with severe cardiac, hepatic, kidney disease
(5)Pregnant women and those at risk of pregnancy, lactating woman
(6)Recruited anothere clinical trial within 6 month
(7)Patients who the doctor judged inaproppriate for the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomokazu Matsuoka |
Organization
University of Yamanashi
Division name
Department of Otorhinolaryngology, Head & Neck Surgery
Zip code
Address
1110 Shimokato, Chuo-shi, Yamanashi-ken, JAPAN
TEL
055-273-6769
tmatsu@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomokazu Matsuoka |
Organization
University of Yamanashi
Division name
Department of Otorhinolaryngology, Head & Neck Surgery
Zip code
Address
1110 Shimokato, Chuo-shi, Yamanashi-ken, JAPAN
TEL
055-273-6769
Homepage URL
tmatsu@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
TORII PHARMACEUTICAL CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yamahoshi ENT Clinic
TORII PHARMACEUTICAL CO.,LTD
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
| 2016 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2016 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 18 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 22 | Day |
Last modified on
| 2018 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027760
