UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053494 |
|---|---|
| Receipt number | R000061038 |
| Scientific Title | Verification of the effectiveness of a pharmacy pharmacist intervention program for safe continuation of drug use in patients newly taking DPP-4 inhibitors |
| Date of disclosure of the study information | 2024/02/02 |
| Last modified on | 2024/01/31 14:44:15 |
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Basic information
Public title
Verification of the effectiveness of a community pharmacist intervention program for safe continuation of medication in patients newly taking DPP-4 inhibitors
Acronym
Verification of the effectiveness of a pharmacy pharmacist intervention program for safe continuation of drug use in patients newly taking DPP-4 inhibitors
Scientific Title
Verification of the effectiveness of a pharmacy pharmacist intervention program for safe continuation of drug use in patients newly taking DPP-4 inhibitors
Scientific Title:Acronym
Verification of the effectiveness of a pharmacy pharmacist intervention program for safe continuation of drug use in patients newly taking DPP-4 inhibitors
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With the aim of providing effective pharmaceutical management that contributes to early detection and early response to gastrointestinal symptoms caused by DPP-4 inhibitors, we will construct an intervention program conducted by pharmacists and verify the effectiveness of the intervention.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients who suspected gastrointestinal symptoms caused by DPP4 inhibitors and reported them to their doctor through medicotion inquiry or tracing Report
Key secondary outcomes
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
Medication follow-up and medication guidance using the developed follow-up sheet will be conducted in accordance with the period when side effects of gastrointestinal symptoms are most likely to occur.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who started taking new DPP-4 inhibitors.
Key exclusion criteria
Patients taking antipsychotics, antidepressants, or corticosteroids.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ayana |
| Middle name | |
| Last name | Funabashi |
Organization
Osaka Medical and Pharmaceutical University
Division name
graduate student
Zip code
569-1041
Address
4-20-1 Nasahara, Takatsuki-shi, Osaka-fu, Japan
TEL
080-8282-6882
ainj08082826882@docomo.ne.jp
Public contact
Name of contact person
| 1st name | Ayana |
| Middle name | |
| Last name | Funabashi |
Organization
Osaka Medical and Pharmaceutical University
Division name
graduate student
Zip code
569-1041
Address
4-20-1 Nasahara, Takatsuki-shi, Osaka-fu, Japan
TEL
080-8282-6882
Homepage URL
ainj08082826882@docomo.ne.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Ayana Funabashi
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
AIN Group Medical Studies Ethics Review Committee
Address
JRsouthMinami Shinjuku Building1F, 2-1-5 Yoyogi, Shibuya-ku, Tokyo-to, Japan
Tel
03-5333-1818
iren@ainj.co.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
| 2024 | Year | 02 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 08 | 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 | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061038
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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