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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023782
Receipt No. 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 2019/03/15

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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
Email 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
Email y_sakuma@hospital.asahi.chiba.jp

Sponsor
Institute Asahi general hospital
Institute
Department

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
Email 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
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
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 26 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027355

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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