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

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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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name