UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057792 |
|---|---|
| Receipt number | R000066033 |
| Scientific Title | A Study on Injection Pain Caused by Subcutaneous Administration of Biologics in Patients with Bronchial Asthma |
| Date of disclosure of the study information | 2025/05/07 |
| Last modified on | 2025/05/07 18:15:51 |
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Basic information
Public title
A Study on Injection Pain Caused by Subcutaneous Administration of Biologics in Patients with Bronchial Asthma
Acronym
A Study on Injection Pain by Subcutaneous Administration of Biologics
Scientific Title
A Study on Injection Pain Caused by Subcutaneous Administration of Biologics in Patients with Bronchial Asthma
Scientific Title:Acronym
A Study on Injection Pain by Subcutaneous Administration of Biologics
Region
| Japan |
Condition
Condition
bronchial asthma, diabetes
Classification by specialty
| Pneumology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the degree of pain caused by biologic injections and its associated factors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between the severity of injection pain from biologic therapies and the willingness to continue treatment
Key secondary outcomes
Effect of pressure or cooling on the reduction of injection-related pain.
Association between injection pain from biologic therapies and various clinical parameters.
Difference of injection pain between subcutaneous formulations used in diabetic and bronchial asthma patients.
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
Patients with bronchial asthma receiving biologic therapy and patients with diabetes receiving subcutaneous injections via auto-injectors
Key exclusion criteria
Patients for whom it is difficult to obtain a questionnaire from the individual due to severe dementia, mental illness, or other conditions. Patients currently using regular analgesics. Patients who have complained of pain prior to the initiation of biologic therapy. Other cases deemed unsuitable by the attending physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Matsumoto |
Organization
Saiseikai-Noe Hospital
Division name
Respiratory Medicine
Zip code
5360001
Address
1-3-25 Furuichi, Jyoto-ku, Osaka
TEL
0669320401
mtakeshi@noe.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Wakita |
Organization
Saiseikai-Noe Hospital
Division name
General Affairs Department
Zip code
5360001
Address
1-3-25 Furuichi, Jyoto-ku, Osaka
TEL
0669320401
Homepage URL
yutaka.wakita@noe.saiseikai.or.jp
Sponsor or person
Institute
Saiseikai-Noe Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saiseikai-Nakatsu Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai-Noe Hospital
Address
1-3-25 Furuichi, Jyoto-ku, Osaka
Tel
0669320401
yutaka.wakita@noe.saiseikai.or.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
Other administrative information
Date of disclosure of the study information
| 2025 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 05 | Month | 07 | Day |
Last modified on
| 2025 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066033
