UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054225 |
|---|---|
| Receipt number | R000061916 |
| Scientific Title | Basic research on new PTP packaging and pictogram creation for the purpose of preventing accidental ingestion of medicines in children. |
| Date of disclosure of the study information | 2024/04/22 |
| Last modified on | 2024/04/22 19:11:45 |
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Basic information
Public title
Basic research on new PTP packaging and pictogram creation for the purpose of preventing accidental ingestion of medicines in children.
Acronym
Research on new drug packaging and pictogram creation for the purpose of preventing accidental ingestion of drugs in children.
Scientific Title
Basic research on new PTP packaging and pictogram creation for the purpose of preventing accidental ingestion of medicines in children.
Scientific Title:Acronym
Research on new drug packaging and pictogram creation for the purpose of preventing accidental ingestion of drugs in children.
Region
| Japan |
Condition
Condition
Healthy child, Healthy elderly
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to support patients to continue medication treatment at home with peace of mind, we will cooperate with pharmaceutical companies to provide CR packaging to medical facilities to prevent children from accidentally ingesting medicines.
Although CR packaging is effective in preventing accidental ingestion of medicines by children, it may hinder the elderly from taking their medicines because it takes time to open the package when taking the medicine. In other words, the challenge is to achieve both CR packaging and senior-friendly packaging.
In addition, a new pictogram to prevent accidental ingestion will directly alert children to the fact that they themselves are taking the medication, and will be a more effective measure to prevent accidental ingestion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time required to open
Key secondary outcomes
Opening of the child
1)Deterrence of accidental ingestion in children
2) How to open the package
Opening of the Elderly
1) Easy to see
2) Easy to open
3) Adverse effects of CR packaging on medication compliance
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
After obtaining the consent of healthy Japanese children living in Japan who do not have a habit of taking medication and their guardians, a video will be taken of the children actually opening the CR packaging.
A pictogram questionnaire will be conducted for the subjects who performed children to prevent accidental ingestion. The accidental ingestion prevention pictogram used in the questionnaire was an original one devised by a professional illustrator. Ask them to select the most appropriate one from the six types.
After obtaining consent from healthy elderly Japanese living in Japan, the participants will be asked to read the instructions on how to open the CR packaging, and a video will be taken of them actually opening the package.
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
Those who have explained the contents of this study and have confirmed the consent statement by the consent form.
Key exclusion criteria
Those who did not get consent.
Persons with physical symptoms that interfere with the opening of drug packaging.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sadahiko |
| Middle name | |
| Last name | Shimoeda |
Organization
Tokyo University of Pharmacy and Life Sciences
Division name
Department of Pharmacy Pharmaceutical Care and Sciences
Zip code
192-0392
Address
1432-1 Horinouchi, Hachioji
TEL
042-676-6697
shimoeda@toyaku.ac.jp
Public contact
Name of contact person
| 1st name | Sadahiko |
| Middle name | |
| Last name | Shimoeda |
Organization
Tokyo University of Pharmacy and Life Sciences
Division name
Department of Pharmacy Pharmaceutical Care and Sciences
Zip code
192-0392
Address
1432-1 Horinouchi, Hachioji
TEL
042-676-6697
Homepage URL
shimoeda@toyaku.ac.jp
Sponsor or person
Institute
Tokyo University of Pharmacy and Life Sciences
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee for Research Utilization of Human Tissues, etc.
Address
1432-1 Horinouchi, Hachioji Tokyo University of Pharmacy and Life Sciences Teaching and Learning IR Research Promotion Division (Ethics Review Committee Secretariat)
Tel
042-676-5349
rinri-office-ml@toyaku.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
社会福祉法人 敬愛学園 敬愛保育園(東京都)/KEIAI GAKUEN Social Well-being Corporation
めじろ台老人会(東京都)/ Mejirodai Elderly Association
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 22 | 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
| 2023 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061916
| Research Plan | |
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| 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 |
