UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007584 |
|---|---|
| Receipt number | R000008800 |
| Scientific Title | The efficacy and safety of ramelteon in prevention of postoperative delirium in the elderly |
| Date of disclosure of the study information | 2012/05/01 |
| Last modified on | 2012/03/27 18:34:17 |
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Basic information
Public title
The efficacy and safety of ramelteon in prevention of postoperative delirium in the elderly
Acronym
The efficacy and safety of ramelteon in prevention of postoperative delirium in the elderly
Scientific Title
The efficacy and safety of ramelteon in prevention of postoperative delirium in the elderly
Scientific Title:Acronym
The efficacy and safety of ramelteon in prevention of postoperative delirium in the elderly
Region
| Japan |
Condition
Condition
postoperative delirium
Classification by specialty
| Hepato-biliary-pancreatic surgery | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of ramelteon in prevention of postoperative delirium in the elderly by randomized double-blinded placebo-controlled study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome was the occurrence of delirium as determined by Confusion Assessment Methods-ICU (CAM-ICU) criteria at day 1,2,3,and 7 after operation.
Key secondary outcomes
The secondary outcome was the degree of severity of delirium as determined by Method Delirium Assessment Scale (MDAS)
criteria if postoperative delirium occurs.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Control group are received placebo capsule (lactose) 8mg before two hours at sleep time every night at least two weeks before operation day.
Interventions/Control_2
Ramelteon 4mg group are received Ramelteon capsule 4mg before two hours at sleep time every night at least two weeks before operation day.
Interventions/Control_3
Ramelteon 8mg group are received Ramelteon capsule 8mg before two hours at sleep time every night at least two weeks before operation day.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged over 65 years scheduled for operation at Kobe University Hospital Hepato-biliary-pancreatic surgery.
Key exclusion criteria
1 Patients with a history of hypersensitivity to this drug.
2 Patients with severe hepatic dysfunction.
3 Patients treated with Fluvoxamine maleate.
4 Patients judged to be unsuitable.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akitoyo Hishimoto |
Organization
Kobe University Hospital
Division name
Psychiatry and Neurology
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, Hyogo pref.
TEL
078-382-6065
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoichi Shiroiwa |
Organization
Kobe University Hospital
Division name
Psychiatry and Neurology
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, Hyogo pref.
TEL
078-382-6065
Homepage URL
kyoichis@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of psychiatry, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of psychiatry, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Kobe University Hospital Hepato-Biliary-Pancreatic Surgery
Department of Hospital Pharmacy, Kobe University Hospital
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
神戸大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 27 | Day |
Last modified on
| 2012 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008800
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| Registered date | File name |
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| Registered date | File name |
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