UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047550 |
|---|---|
| Receipt number | R000054228 |
| Scientific Title | Open-label, multicenter, randomized, parallel-group comparative study for the utility of telephone follow-up in community pharmacies for the detection of triple whammy in multiple drug combination patients |
| Date of disclosure of the study information | 2022/04/21 |
| Last modified on | 2025/08/13 15:30:36 |
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Basic information
Public title
Comparison of concomitant drug confirmation methods in community pharmacies for patients using multiple drugs
Acronym
Comparison of concomitant drug confirmation methods in community pharmacies
Scientific Title
Open-label, multicenter, randomized, parallel-group comparative study for the utility of telephone follow-up in community pharmacies for the detection of triple whammy in multiple drug combination patients
Scientific Title:Acronym
Comparison of concomitant drug confirmation methods in community pharmacies for detection of triple whammy in multiple drug combination patients
Region
| Japan |
Condition
Condition
Patients prescribed diuretics and renin-angiotensin system inhibitors (angiotensin converting enzyme inhibitors; ACEI or angiotensin II receptor blockers; ABR)
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of concomitant drug confirmation methods in community pharmacies for detection of triple whammy in multiple drug combination patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number and type of concomitant drugs
Key secondary outcomes
Number of pharmacists consultation to prescribing physician, and renal function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Telephone follow-up
Interventions/Control_2
Follow-up in community pharmacy at next visit
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who take prescriptions to the study participating pharmacy
2. Patients on a dual combination of a diuretic and ACEI or ARB
Key exclusion criteria
1. Patients who failed to obtain consent to the study
2. Patients or agents unable to respond to telephone calls, such as cognitive decline or hearing loss
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Saki |
| Middle name | |
| Last name | Kashikawa |
Organization
Shiga Pharmaceutical Association Kaiei Pharmacy
Division name
Pharmacy
Zip code
525-0072
Address
7-4-52, Kasayama, Kusatsu city, Shiga, Japan.
TEL
077-567-2435
kaiei@shigayaku.or.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Kashikawa |
Organization
Shiga Pharmaceutical Association Kaiei Pharmacy
Division name
Pharmacy
Zip code
525-0072
Address
7-4-52, Kasayama, Kusatsu city, Shiga, Japan.
TEL
077-567-2435
Homepage URL
kaiei@shigayaku.or.jp
Sponsor or person
Institute
Shiga Pharmaceutical Association Kaiei Pharmacy
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethical Committee of Shiga Pharmaceutical Association
Address
7-4-52, Kasayama, Kusatsu city, Shiga, Japan.
Tel
077-565-3535
okamoto@shigayaku.or.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
| 2022 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jjphcs/51/8/51_476/_article/-char/ja
Number of participants that the trial has enrolled
105
Results
The percentage of confirmed concomitant medications was significantly higher in the telephone follow-up group (97.6%) compared with 63.5% in the conventional counter-confirmation group (P < 0.01), and the percentage of confirmed NSAIDs (ie, triple whammy detection) was also significantly higher in the telephone follow-up group (P < 0.01).
Results date posted
| 2025 | Year | 08 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 08 | Month | 10 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2022 | Year | 04 | Month | 21 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054228
