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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024796
Receipt No. R000028529
Scientific Title Evaluation of po suvorexant for delirium in ICU ventilated patients
Date of disclosure of the study information 2016/11/11
Last modified on 2017/11/22

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Basic information
Public title Evaluation of po suvorexant for delirium in ICU ventilated patients
Acronym Evaluation of po suvorexant in ICU patients
Scientific Title Evaluation of po suvorexant for delirium in ICU ventilated patients
Scientific Title:Acronym Evaluation of po suvorexant in ICU patients
Region
Japan

Condition
Condition insomnia
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of administration of suvorexant via gastric tube in ICU.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes frequency of insomnia, dose of sedative agents
Key secondary outcomes frequency of delirium, dose of vasopressor

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of suborexant via gastric tube(half dose)
Interventions/Control_2 Administration of suborexant via gastric tube
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
100 years-old >
Gender Male and Female
Key inclusion criteria Patient who need mechanical ventilation and expected to stay ICU for 24 hours
Key exclusion criteria ・Severe liver disfunction
・Patient who need continuous sedation throughout day
・Gastrointestinal dysfunction
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kansuke Koyama
Organization Jichi Medical University hospital
Division name Department of Anesthesiology and Intensive care Medicine
Zip code
Address 3311-1 Yakushiji Shimotsuke-shi, Tochigi
TEL 0285-58-7392
Email k_koyama@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kansuke Koyama
Organization Jichi Medical University hospital
Division name Department of Anesthesiology and Intensive care Medicine
Zip code
Address 3311-1 Yakushiji Shimotsuke-shi, Tochigi
TEL 0285-58-7392
Homepage URL
Email k_koyama@jichi.ac.jp

Sponsor
Institute Jichi Medical university hospital
Institute
Department

Funding Source
Organization Jichi Medical 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 11 Month 11 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 11 Month 11 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 14 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 11 Month 11 Day
Last modified on
2017 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028529

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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