UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060999 |
|---|---|
| Receipt number | R000069805 |
| Scientific Title | Effect of pharmacist-led educational intervention on switching to generic medicine among patients using brand-name medicines in Japan |
| Date of disclosure of the study information | 2026/03/20 |
| Last modified on | 2026/03/20 20:22:41 |
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Basic information
Public title
Effect of pharmacist-led educational intervention on switching to generic medicine among patients using brand-name medicines
Acronym
Study on pharmacist-led educational intervention for patients using brand-name medicines
Scientific Title
Effect of pharmacist-led educational intervention on switching to generic medicine among patients using brand-name medicines in Japan
Scientific Title:Acronym
Study on pharmacist-led educational intervention for patients using brand-name medicines
Region
| Japan |
Condition
Condition
Patients using brand-name medicines
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate whether patients using brand-name medicines, who had limited knowledge and low perception of generic medicine, would switch from brand-name medicines to generic medicine following pharmacist-led educational intervention. Additionally, we compared the knowledge and perceptions of generic medicine before and after the intervention and assessed whether these findings contributed to an increase in the number of patients switching from brand-name medicines to generic medicine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of patients using brand-name medicines before and after the pharmacist-led educational intervention
Key secondary outcomes
Changes in knowledge and perception regarding generic medicine
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
In this study, the educational intervention consisted of pharmacists providing standardized explanations using pamphlets about generic medicine (GE) to patients who preferred brand-name medicines and allocating time to answer questions. The content covered GE's manufacturing approval processes, efficacy, quality, safety, advantages not present in brand-name medicines [e.g., improved bitterness and dosing convenience], economic benefits of using GE, the background of GE promotion policies, and fees related to patient preference for brand-name medicines. The standardized explanation and Q&A sessions were scheduled to take approximately 20 min. The intervention was scheduled for the second visit.
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have provided informed consent to participate in this study
Patients who have previously used generic medicines
Patients aged 18 to 74 who are using one or more brand-name medicines of their own request
Key exclusion criteria
Patients who wish to use generic medicines for all prescribed medications
Patients who have no prior experience with generic medicines
Patients who were unable to complete all procedures for VISIT 1 and 2 in accordance with the protocol
Patients taking medications to improve cognitive function who were deemed unsuitable due to a lack of understanding regarding the medications
Patients taking psychotropic medications, such as antidepressants or antipsychotics, who were deemed unsuitable due to the high likelihood of causing excessive distress
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Tairabune |
Organization
UNIMAT LIFE Co, Ltd, Regina Pharmacy Jimbo-cho
Division name
Regina Pharmacy Jimbo-cho
Zip code
1010051
Address
1F Tamura building 3-2-4 Kanda Jimbo-cho, Chiyoda-ku, Tokyo
TEL
03-3265-2105
ttairabune@gmail.com
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Tairabune |
Organization
UNIMAT LIFE Co, Ltd, Regina Pharmacy Jimbo-cho
Division name
Regina Pharmacy Jimbo-cho
Zip code
101-0051
Address
1F Tamura building 3-2-4 Kanda Jimbo-cho, Chiyoda-ku, Tokyo
TEL
03-3265-2105
Homepage URL
ttairabune@gmail.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
Japanese Association for Community Pharmacy, Ethics Review Committee for Clinical and Epidemiological Research
Address
1-6-23 Meguro, Meguro-ku, Tokyo
Tel
03-6303-9181
info@ja-cp.org
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
| 2026 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
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
| 2025 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 03 | Month | 20 | Day |
Last modified on
| 2026 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069805
