UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021886 |
|---|---|
| Receipt number | R000023547 |
| Scientific Title | Development of the "Adverse Drug Reaction Monitoring System " using high- performance communication mobile |
| Date of disclosure of the study information | 2016/04/12 |
| Last modified on | 2016/04/12 15:52:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of the "Adverse Drug Reaction Monitoring System "
using high- performance communication mobile
Acronym
Development of the "Adverse Drug Reaction Monitoring System "
Scientific Title
Development of the "Adverse Drug Reaction Monitoring System "
using high- performance communication mobile
Scientific Title:Acronym
Development of the "Adverse Drug Reaction Monitoring System "
Region
| Japan |
Condition
Condition
It does not matter disease
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of the "Adverse Drug Reaction Monitoring System "
using high- performance communication mobile
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Development of the "Adverse Drug Reaction Monitoring System "
using high- performance communication mobile
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
use of high\peformance communication mobile
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
| 0 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patient using high performance comminication mobile
Key exclusion criteria
non consent patient
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Furukawa |
Organization
Yamaguchi University Hospital
Division name
Department of Pharmacy
Zip code
Address
1-1-1, Minamikogushi, Ube-city
TEL
0836-22-2665
sambista-knz@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Furukawa |
Organization
Yamaguchi University Hospital
Division name
DEpartment of Pharmacy
Zip code
Address
1-1-1, Minamikogushi, Ube-city
TEL
0836-22-2665
Homepage URL
sambista-knz@umin.ac.jp
Sponsor or person
Institute
Yamaguchi University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University 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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 12 | 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
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 12 | 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
| 2016 | Year | 04 | Month | 12 | Day |
Last modified on
| 2016 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023547
