UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016471
Receipt number R000019132
Scientific Title A randomized clinical trial of delirium prevention
Date of disclosure of the study information 2015/03/01
Last modified on 2017/07/15 19:19:31

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Basic information

Public title

A randomized clinical trial of delirium prevention

Acronym

A randomized clinical trial of delirium prevention

Scientific Title

A randomized clinical trial of delirium prevention

Scientific Title:Acronym

A randomized clinical trial of delirium prevention

Region

Japan


Condition

Condition

delirium

Classification by specialty

Psychiatry Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We aim to examine whether suvorexant is effective for prevention of delirium, or not.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Incidence of delirium

Key secondary outcomes

Discontinuation due to adverse phenomenon


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Suvorexant
7days
between 20 and 64 years of age :20mg
65 years ofage and older :15mg

Interventions/Control_2

Conventional treatment

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

Patients newly admitted to emergency department

Key exclusion criteria

1) Alcohol dependence, amphetamine abuse
2) under medication with psychoactive drug

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazunari Azuma

Organization

Tokyo Medical University Hospital

Division name

emergency and critical care medicine

Zip code


Address

6-7-1 Nishishinjyuku,Shinjyuku-ku,Tokyo

TEL

03-3342-6111

Email

jpn4077@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazunari Azuma

Organization

Tokyo Medical University Hospital

Division name

emergency and critical care medicine

Zip code


Address

6-7-1 Nishishinjyuku,Shinjyuku-ku,Tokyo

TEL

03-3342-6111

Homepage URL


Email

jpn4077@yahoo.co.jp


Sponsor or person

Institute

Tokyo Medical University Hospital

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical University

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

東京医科大学病院(東京都)      Tokyo Medical University(Tokyo)


Other administrative information

Date of disclosure of the study information

2015 Year 03 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


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

2015 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 05 Month 12 Day

Last follow-up date

2017 Year 02 Month 28 Day

Date of closure to data entry

2017 Year 02 Month 28 Day

Date trial data considered complete

2017 Year 03 Month 10 Day

Date analysis concluded

2017 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 02 Month 07 Day

Last modified on

2017 Year 07 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019132


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name