Basic research on new PTP packaging and pictogram creation for the purpose of preventing accidental ingestion of medicines in children.

UMIN ID: UMIN000054225

Registered date:22/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy child, Healthy elderly
• Date of first enrollment: 2024/04/22
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Time required to open
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Those who did not get consent. Persons with physical symptoms that interfere with the opening of drug packaging.

Related Information

• Primary Sponsor: Tokyo University of Pharmacy and Life Sciences
• Source(s) of Monetary Support: Other