UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043919 |
|---|---|
| Receipt number | R000050156 |
| Scientific Title | Study on the development and feasibility of a side effect monitoring program: a preliminary single-arm study |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2025/04/18 13:25:55 |
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Basic information
Public title
Study on the development and feasibility of a side effect monitoring program: a preliminary single-arm study
Acronym
Study on the development and feasibility of a side effect monitoring program
Scientific Title
Study on the development and feasibility of a side effect monitoring program: a preliminary single-arm study
Scientific Title:Acronym
Study on the development and feasibility of a side effect monitoring program
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether pre-dispensing patient interviews by community pharmacists based on adverse drug reaction mechanism classification can increase the accuracy of adverse drug reaction monitoring and improve the safety of drug therapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of patients with signs of side effects detected among eligible patients
Key secondary outcomes
1)Self-efficacy of pharmacists in preventing adverse drug reactions
2)Patient satisfaction with treatment
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
1) Hearing before dispensing
2) Data entry into the monitoring system
3) Evaluation of side effect symptoms
4) Medication guidance
5) Entry in medication history
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with a prescription of 31 days or less (in principle)
2) Patients who are expected to continue coming to the pharmacy during the follow-up period (3 months)
Key exclusion criteria
1) Patients receiving home visiting drug management guidance by pharmacists
2) Patients who are unable to answer the questionnaire by themselves
3) First-time visitors
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Mitsuko |
| Middle name | |
| Last name | Onda |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Pharmacy
Zip code
569 1094
Address
4-20-1, Nasahara, Takatsuki, Osaka
TEL
+81-72-690-1059
mitsuko.onda@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuko |
| Middle name | |
| Last name | Onda |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Pharmacy
Zip code
569 1094
Address
4-20-1 Nasahara Takatsuki Osaka
TEL
+81-72-690-1059
Homepage URL
mitsuko.onda@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nonprofit Organization Donguri Mirai Juku
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics review Committee of Osaka Medical and Pharmaceutical University
Address
4-20-1, Nasahara, Takatsuki, Osaka
Tel
+81-72-690-1103
kenkyus@ompu.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
330
Results
The percentage of patients who were able to detect adverse drug reactions through the use of this system increased significantly after the intervention, from 20.9% to 33.9%.
The percentage of patients for whom feedback from the pharmacist to the prescribing physician occurred increased from 0.3% to 3.0%.
Results date posted
| 2025 | Year | 04 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subjects were type 2 diabetes patients under 80 years of age who met the following requirements.
the number of days of their prescription is less than 1 month
baseline data available for the past 3 months
expected to continue to visit the clinic during the follow up period
Participant flow
When a patient came to the clinic, symptoms were interviewed prior to the prescription audit, and the presence or absence of suspected side effects was determined using a system equipped with a database of side effect mechanism classifications. If there was a possibility of an adverse drug reaction, the patient was asked to identify the drug and the mechanism by which it might occur before the prescription audit and drug administration guidance were conducted. In order to obtain a comprehensive list of symptoms, patients were interviewed at the time of their first visit to the pharmacy using a sheet that they could fill out themselves.
Adverse events
No adverse events related to the conduct of this study were observed.
Outcome measures
Percentage of patients in whom adverse drug reactions were detected through the use of this system
Percentage of patients for whom feedback from the pharmacist to the prescribing physician occurred
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 04 | Month | 14 | Day |
Last modified on
| 2025 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050156
