UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010475 |
|---|---|
| Receipt number | R000012241 |
| Scientific Title | Determination of the effect of topical glucorticosteroid on the barrier function of human nasal mucosa |
| Date of disclosure of the study information | 2013/04/12 |
| Last modified on | 2017/04/15 11:33:54 |
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Basic information
Public title
Determination of the effect of topical glucorticosteroid on the barrier function of human nasal mucosa
Acronym
Effects of topical glucorticosteroid on the human nasal barrier
Scientific Title
Determination of the effect of topical glucorticosteroid on the barrier function of human nasal mucosa
Scientific Title:Acronym
Effects of topical glucorticosteroid on the human nasal barrier
Region
| Japan |
Condition
Condition
allergic rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect the effect of topical glucocorticoid, pre and post nasal provocation on nasal mucosal barrier
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
nasal transepithelial water loss, nasal potential differences
Key secondary outcomes
clinical symptoms
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
fluticasone furoate
Interventions/Control_2
fluticasone furoate placebo
Interventions/Control_3
mometasone furoate
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese cedar poliinosis
Key exclusion criteria
allergic rhinitis with active inflammation
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | masato miwa |
Organization
Juntendo Universiry
Division name
Otorhinolaryngology
Zip code
Address
3-1-3 Hongo Bunkyo Tokyo
TEL
03-5802-1229
mmiwa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | masato miwa |
Organization
Juntendo Universiry
Division name
Otorhinolaryngology
Zip code
Address
3-1-3 Hongo Bunkyo Tokyo
TEL
03-5802-1229
Homepage URL
mmiwa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
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
順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 12 | Day |
Last modified on
| 2017 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012241
