UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049878 |
|---|---|
| Receipt number | R000056808 |
| Scientific Title | Questionnaire Survey on Dupilumab or Mepolizumab in patients with severe allergic diseaes : The Significance of Self-Injection |
| Date of disclosure of the study information | 2022/12/23 |
| Last modified on | 2022/12/23 01:01:43 |
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Basic information
Public title
Questionnaire Survey on Dupilumab or Mepolizumab in patients with severe allergic diseaes : The Significance of Self-Injection
Acronym
The Significance of Self-Injection of Dupilumab or Mepolizumab in patients with severe allergic diseaes
Scientific Title
Questionnaire Survey on Dupilumab or Mepolizumab in patients with severe allergic diseaes : The Significance of Self-Injection
Scientific Title:Acronym
Questionnaire Survey on Dupilumab or Mepolizumab in patients with severe allergic diseaes
Region
| Japan |
Condition
Condition
Asthma, Atopic dermatitis, Chronic sinusitis with nasal polyps
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a survey on dupilumab or mepolizumab in patients with atopic dermatitis, severe bronchial asthma, or chronic sinusitis with nasal polyps to determine the significance of self-injection.
Basic objectives2
Others
Basic objectives -Others
the significance of self-injection
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Usefulness, Safety, and Medical Economics (Self-payment) of Self-Injection
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with asthma, atopic dermatitis, or chronic sinusitis with nasal polyps requiring biologics
Key exclusion criteria
Subjects who do not consent to the survey
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Muraki |
Organization
Kindai University Nara Hospital
Division name
Department of Respiratory Medicine and Allergology
Zip code
630-0293
Address
1248-1 Otoda-cho, Ikoma, Nara 630-0293, Japan
TEL
0743-77-0880
muraki-m@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Muraki |
Organization
Kindai University Nara Hospital
Division name
Department of Respiratory Medicine and Allergology
Zip code
630-0293
Address
1248-1 Otoda-cho, Ikoma, Nara 630-0293, Japan
TEL
0743-77-0880
Homepage URL
https://www.med.kindai.ac.jp/nara/
muraki-m@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Nara Hospital
Institute
Department
Personal name
Funding Source
Organization
Kindai University Nara Hospital
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
Kindai University Nara Hospital
Address
1248-1 Otoda-cho, Ikoma, Nara 630-0293, Japan
Tel
0743-77-0880
muraki-m@med.kindai.ac.jp
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
近畿大学奈良病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questionnaire survey
Comparison of pen and syringe formulations
Reduction of the burden of self-injection
Annual income
Efficacy, adverse events, satisfaction
Management information
Registered date
| 2022 | Year | 12 | Month | 23 | Day |
Last modified on
| 2022 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056808
| 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 |
