UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003950 |
|---|---|
| Receipt number | R000004757 |
| Scientific Title | sublingual immunotherapy for Japanese cedar pollinosis: multicenter trial |
| Date of disclosure of the study information | 2010/07/27 |
| Last modified on | 2013/02/02 12:31:28 |
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Basic information
Public title
sublingual immunotherapy for Japanese cedar pollinosis: multicenter trial
Acronym
SLIT for Japanese cedar pollinosis
Scientific Title
sublingual immunotherapy for Japanese cedar pollinosis: multicenter trial
Scientific Title:Acronym
SLIT for Japanese cedar pollinosis
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Clinical immunology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluate the efficacy and safety of sublingual immunothterapy for Japanese cedar pollinosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
nasal symptoms score (diary)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
administraion standerdised Jaanese cedar extract sublingually for 2minute and then spit the extract
Interventions/Control_2
administraion placebo sublingually for 2minute and then spit
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patient with allergic rhinitis, who have specific IgE RAST (cedar pollen) score 2 in the past 2years.
2) Patient who have nasal obstruction, and typical allergic rhinitis symptoms for at least 2 years.
3) Written informed consent is required.
Key exclusion criteria
1) Patients with disease which make objective evaluation difficult.
* infection disease
* nonallergic rhinitis
* medicamentosa
2) Anti-allergy drug treatment within two weeks of study entry.
3) Patients who have received immunotherapy.
4) Allergic Rhinitis patients who underwent laser surgery and operation within 6 months.
5) Uncontrolled asthma patients
6) Patients who have the hypersensitivity to study drugs
7) Infectious diseases and mycosis, with no effective therapeutic drug.
8) Pregnant or lactating women and women with possibility of pregnancy.
9) Patients who were judged to be unsuitable for patient enrollment by their doctor.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Gotoh |
Organization
Nippon Medical School
Division name
Otorhinolarygology
Zip code
Address
1-1-5 sendagi bunkyo-ku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nippon Medical School
Division name
Otorhinolaryngology
Zip code
Address
TEL
03-3822-2131
Homepage URL
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
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
| 2010 | Year | 07 | Month | 27 | 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
| 2003 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | 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
| 2010 | Year | 07 | Month | 26 | Day |
Last modified on
| 2013 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004757
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
