UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005825 |
|---|---|
| Receipt number | R000006774 |
| Scientific Title | Diagnosis of aspirin intolerance in chronic rhinosinusitis by intranasal provocation test of aspirin |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2013/01/25 15:34:29 |
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Basic information
Public title
Diagnosis of aspirin intolerance in chronic rhinosinusitis by
intranasal provocation test of aspirin
Acronym
intranasal aspirin provocation test
Scientific Title
Diagnosis of aspirin intolerance in chronic rhinosinusitis by
intranasal provocation test of aspirin
Scientific Title:Acronym
intranasal aspirin provocation test
Region
| Japan |
Condition
Condition
intractable chronic rhinosinusitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate aspirin intolerance
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluatation of the asprin intolerance by nasal application
Key secondary outcomes
safety of the asprin intolerance by nasal application
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
recurrent chronic rhinosinusitis with nasal polyps
Key exclusion criteria
aspirin intolerance previously detected
subjects receving systemic steroid administration within 1 week
severe asthma
unsuitable subjects judged by examinaters
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | katsuhisa ikeda |
Organization
Juntendo University Faculty of Medicine
Division name
Otorhinolaryngology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku
TEL
03-5802-1094
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University Faculty of Medicine
Division name
Otyorhinolaryngology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku
TEL
Homepage URL
chiken@juntendo.ac.jp
Sponsor or person
Institute
Department of Otohinolaryngology, Juntendo University Faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Otohinolaryngology, Juntendo University Faculty of medicine
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Eighty ul of saline with 100mg aspirin are introdued into the nasal cavity and the nasal symptoms are observed. The severity of the nasal symptpms is evaluated by the score. The rhinomanometry si performed before the examaniation.
Management information
Registered date
| 2011 | Year | 06 | Month | 21 | Day |
Last modified on
| 2013 | 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=R000006774
| 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 |
