UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035967 |
|---|---|
| Receipt number | R000040967 |
| Scientific Title | Effect of L-92 for ECRS |
| Date of disclosure of the study information | 2019/02/21 |
| Last modified on | 2019/09/03 12:31:59 |
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Basic information
Public title
Effect of L-92 for ECRS
Acronym
ECRS and L-92
Scientific Title
Effect of L-92 for ECRS
Scientific Title:Acronym
ECRS and L-92
Region
| Japan |
Condition
Condition
Eosinophilic rhinosinusitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assesment of L-92 for ECRS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endoscopic paranasal score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Addministration of L-92 once a day.
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
ECRS patients with prior-surgery30
Key exclusion criteria
Under 20 years old
oral PSL user
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kosuke Akiyama |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Otolaryngology
Zip code
Address
Kita-gun, Miki-cho, Ikenobe 1750-1, Kagawa 761-0793, Japan
TEL
087-891-2214
kakaka@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Akiyama |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Otolaryngology
Zip code
Address
+81-087-891-2214
TEL
087-891-2214
Homepage URL
kakaka@med.kagawa-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, Kagawa University
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
| 2019 | Year | 02 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 09 | Month | 05 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 21 | Day |
Last modified on
| 2019 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040967
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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