UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023782 |
|---|---|
| Receipt number | R000027355 |
| Scientific Title | Randomized controled trial to examine the efficacy and safety of demedicative intervention for polypharmacy in the Japanese elderly patients |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2022/08/31 11:14:13 |
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Basic information
Public title
Randomized controled trial to examine the efficacy and safety of demedicative intervention for polypharmacy in the Japanese elderly patients
Acronym
No Polypharmacy Trial
Scientific Title
Randomized controled trial to examine the efficacy and safety of demedicative intervention for polypharmacy in the Japanese elderly patients
Scientific Title:Acronym
No Polypharmacy Trial
Region
| Japan |
Condition
Condition
Polypharmacy of elderly patients
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination for the safety of reduction of multiple drugs prescribed for the elderly patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increase of AE
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
reduction of drugs more than two at once
Interventions/Control_2
no intentional reduction of drugs
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)75y.o. or more
2)More than 6 prescription
3)The patient who can be reduced of the prescribed drugs more than two at once. One of the reduction of drugs should be achieved by using the mixed pill of those drugs. The other reduction should be done according to the appropriate medication list for the elderly patients.
4)Adherence of the prescription should be more than 50%
5)Document agreement of the patients with sufficient understanding of the study and freedom for rejection
Key exclusion criteria
1)Psychiatric patients not under adequate control
2)Patients with dementia
3)All of the other patients who are decided not to be adequate for enrollment by responsible researcher
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Kobayashi |
Organization
Asahi general hospital
Division name
Department of diabetes and metabolism
Zip code
289-2511
Address
i-1326, Asahi city, Chiba, 289-2511 Japan
TEL
0479-63-8111
koba-chi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yukie |
| Middle name | |
| Last name | Sakuma |
Organization
Asahi general hospital
Division name
Clinical research support center
Zip code
289-2511
Address
i-1326, Asahi city, Chiba, 289-2511 Japan
TEL
0479-63-8111
Homepage URL
y_sakuma@hospital.asahi.chiba.jp
Sponsor or person
Institute
Asahi general hospital
Institute
Department
Personal name
Funding Source
Organization
Asahi general hospital
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
Asahi general hospital
Address
i-1326, Asahi city, Chiba, 289-2511 Japan
Tel
0479-63-8111
tinoue@hospital.asahi.chiba.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
| 2016 | Year | 09 | Month | 01 | 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
43
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because of transfer of the corresponding researcher to the next department.
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 26 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 26 | Day |
Last modified on
| 2022 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027355
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
