UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027355