UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010657 |
|---|---|
| Receipt number | R000012392 |
| Scientific Title | Validation study about priming effect and the day after day revelation in an artifical exposure chamber(OHIO Chamber). |
| Date of disclosure of the study information | 2013/05/07 |
| Last modified on | 2018/01/25 13:45:05 |
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Basic information
Public title
Validation study about priming effect and the day after day revelation in an artifical exposure chamber(OHIO Chamber).
Acronym
Validation study about priming effect and the day after day revelation in an artifical exposure chamber(OHIO Chamber).
Scientific Title
Validation study about priming effect and the day after day revelation in an artifical exposure chamber(OHIO Chamber).
Scientific Title:Acronym
Validation study about priming effect and the day after day revelation in an artifical exposure chamber(OHIO Chamber).
Region
| Japan |
Condition
Condition
Japanese cedar Pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is intended that I examine it in OHIO Chaber how you have an influence day after day again by time of the revelation how you have an influence on the onset of later nasal symptom by priming revelation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptoms score (Nasal)
Key secondary outcomes
1)Nasal secretion volume
2)Number of sneezing
3)Occurrence time of first nasal symptoms
4)Bitterness of the symptom(VAS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
14 subjects receive cedar pollen exposure in continuation (2hours,4hours,3hours or 2hours,6hours,4hours) for three days.
The one week later, 14 subjects receive cedar pollen exposure equally in two days consecutive (4hours,3hours or 6hours,4hours).
Interventions/Control_2
14 subjects receive cedar pollen exposure in continuation (4hours,3hours or 6hours,4hours) for two days.
The one week later, 14 subjects receive cedar pollen exposure equally in three days consecutive (2hours,4hours,3hours or 2hours,6hours,4hours).
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)CAPRAST score against Japanese cedar pollen over class 2 within the last 2 years.
2)Patient whom the nose symptom that was apparent to the cedar pollen scattering period this year developed in.
3)Written informed concent is required.
Key exclusion criteria
1)Patients with mucosal lesion of the nose and eyes.
2)Patients who received steroid injections within 6 months.
3)
4)Patients with respiratory disease such as asthma.
5)Patients with past history of anaphylaxis.
6)Patients who have receiving immunotherapy.
7)Patients who were judged to be unsuitable for patient enrollment by their doctor.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Hashiguchi |
Organization
Futaba otolaryngology clinic
Division name
Futaba otolaryngology clinic
Zip code
Address
Yotsuya Medical Bldg 2F.,20,Samoncho,Shinjuku-ku,Tokyo,Japan,160-0017
TEL
03-3351-4133
k_hashiguchiiii@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoko Shimizu |
Organization
Tokyo Reserch Center of Clinical Pharmacology co.,ltd.
Division name
Customer Relations Dept.
Zip code
Address
Yotsuya Medical Bldg 4F.,20,Samoncho,Shinjuku-ku,Tokyo,Japan,160-0017
TEL
03-5366-3454
Homepage URL
s-shimizu@trcp.co.jp
Sponsor or person
Institute
Samoncho Clinic
Institute
Department
Personal name
Funding Source
Organization
Samoncho Clinic
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
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
医療法人社団 信濃会 左門町クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 07 | 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
| 2013 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 11 | 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
| 2013 | Year | 05 | Month | 07 | Day |
Last modified on
| 2018 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012392
