UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006341 |
|---|---|
| Receipt number | R000007521 |
| Scientific Title | A randomized, open-label trial of ramelteon to prevent postoperative delirium in patients undergoing coronary artery bypass grafting |
| Date of disclosure of the study information | 2011/09/13 |
| Last modified on | 2011/09/13 20:39:51 |
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Basic information
Public title
A randomized, open-label trial of ramelteon to prevent postoperative delirium in patients undergoing coronary artery bypass grafting
Acronym
Trial of ramelteon to prevent postoperative delirium in patients undergoing coronary artery bypass grafting
Scientific Title
A randomized, open-label trial of ramelteon to prevent postoperative delirium in patients undergoing coronary artery bypass grafting
Scientific Title:Acronym
Trial of ramelteon to prevent postoperative delirium in patients undergoing coronary artery bypass grafting
Region
| Japan |
Condition
Condition
coronary artery bypass grafting
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
prevention of postoperative delirium
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence rate of postoperative delirium
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
intervention group ramelteon 8mg continuous administration for three days after operation
Interventions/Control_2
non intervention group
drug free
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
none
Key exclusion criteria
hepatic impairment
taking fluvoxamine maleate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | motohide furuya |
Organization
Shimane University faculty of medicine
Division name
psychiatry
Zip code
Address
89-1 Enya-cho, Izumo, Shimane
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
psychiatry
Division name
89-1 Enya-cho, Izumo, Shimane
Zip code
Address
TEL
0853-20-2260
Homepage URL
Sponsor or person
Institute
Shimane University faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2011 | Year | 09 | Month | 13 | 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
| 2011 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | 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
| 2011 | Year | 09 | Month | 13 | Day |
Last modified on
| 2011 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007521
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
