UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024512 |
|---|---|
| Receipt number | R000028211 |
| Scientific Title | Community pharmacist-based memantine medication counseling to improve medication adherence - PASM-study - |
| Date of disclosure of the study information | 2016/10/21 |
| Last modified on | 2018/09/20 22:14:38 |
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Basic information
Public title
Community pharmacist-based memantine medication counseling to improve medication adherence - PASM-study -
Acronym
PASM-study
Scientific Title
Community pharmacist-based memantine medication counseling to improve medication adherence - PASM-study -
Scientific Title:Acronym
PASM-study
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of medication counseling intervation on the use of memantine with educational brochure by community pharmacist
Basic objectives2
Others
Basic objectives -Others
Medication persistence rate
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Medication persistence rate at 24 weeks
Key secondary outcomes
Medication Possession Ratio
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intensive medication counseling using educational brochure
Interventions/Control_2
Usual medication counseling
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patient who is/was newly prescribed memantine
2.Patient whom oral consent has been obtained for only the group of intensive medication counseling using educational brochure
Key exclusion criteria
-
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiko Yamamura |
Organization
School of Pharmacy, Aichi Gakuin University
Division name
Clinical Pharmacy
Zip code
Address
1-100 Kusumoto-cho, Chikusa-ku, Nagoya
TEL
052-757-6767
keiko-y@dpc.agu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norio Watanabe |
Organization
School of Pharmacy, Aichi Gakuin University
Division name
Clinical Pharmacy
Zip code
Address
1-100 Kusumoto-cho, Chikusa-ku, Nagoya
TEL
052-757-6766
Homepage URL
norio-w@dpc.agu.ac.jp
Sponsor or person
Institute
Clinical Pharmacy, School of Pharmacy, Aichi Gakuin University
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
MEM-DS-15016
Org. issuing International ID_1
DAIICHI SANKYO CO., LTD.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
株式会社ファーマホールディング（北海道）、株式会社サンメディック（東京都）、株式会社シー・アール・メディカル（愛知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2016 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 02 | Month | 19 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 21 | Day |
Last modified on
| 2018 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028211
