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 |
* 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
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
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
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
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
