UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028020 |
|---|---|
| Receipt number | R000032086 |
| Scientific Title | Evaluation of usability of Newly developed medication assist device of tablet |
| Date of disclosure of the study information | 2017/07/04 |
| Last modified on | 2018/01/03 14:38:36 |
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Basic information
Public title
Evaluation of usability of Newly developed medication assist device of tablet
Acronym
Usability of Newly developed medication assist device of tablet
Scientific Title
Evaluation of usability of Newly developed medication assist device of tablet
Scientific Title:Acronym
Usability of Newly developed medication assist device of tablet
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to evaluate the usability of a medication assist device in healty volunteers and erderly patients.
Basic objectives2
Others
Basic objectives -Others
usability
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to complete to put out the tablets from the device.
Key secondary outcomes
Questionnaire survey for usability
Evaluation of usability observed by evaluators.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Medication assist device of tablets
Interventions/Control_2
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
Healthy volunteers (20-40 y.o.) and elderly patients (>=65 y.o.)
Key exclusion criteria
1. Severely functional disorder in hand or fingers
2. Unable to communicate
3. Unable to obtain the consent to join this study
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Namiki |
Organization
School of Pharmaceutical Sciences University of Shizuoka
Division name
Department of Pharmacy Practice and Science
Zip code
Address
52-1, Yada, Surugaku, Shizuoka
TEL
054-264-5234
uchidas@u-shiuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya UCHIDA |
Organization
School of Pharmaceutical Sciences University of Shizuoka
Division name
Department of Pharmacy Practice and Science
Zip code
Address
Department of Pharmacy Practice and Science
TEL
054-264-5234
Homepage URL
uchidas@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka, School of Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Otuka Pharmaceutical 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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
静岡県立大学（静岡県）、レモン薬局（静岡県）、やまうち薬局（静岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 30 | Day |
Last modified on
| 2018 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032086
