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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007584
Receipt No. 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

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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
Email

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
Email kyoichis@med.kobe-u.ac.jp

Sponsor
Institute Department of psychiatry, Kobe University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008800

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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