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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018697
Receipt No. R000021458
Scientific Title A phase II study of ramelteon on preventive of postoperative delirium after gastrectomy in elderly patinet
Date of disclosure of the study information 2015/08/17
Last modified on 2016/03/18

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Basic information
Public title A phase II study of ramelteon on preventive of postoperative delirium after gastrectomy in elderly patinet
Acronym A phase II study of ramellteon on preventive of postoperative delirium
Scientific Title A phase II study of ramelteon on preventive of postoperative delirium after gastrectomy in elderly patinet
Scientific Title:Acronym A phase II study of ramellteon on preventive of postoperative delirium
Region
Japan

Condition
Condition Gastric cnacer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine effect of ramelteon on preventive of postoperative delirium after gastrectomy in elderly patient
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Incidence of postoperative delirium
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Ramelteon 8mg/day is administered after dinner from 7 days to previous day before operation. Ramelton is also administered after operation from initiation of drinking water to discharge.
Interventions/Control_2
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Histologically proven adenocarcinoma of the stomach.
2.Gastrectomy, not partial resection, is planned.
3. Age is greater than or equal to 75 years old.
4. Eeatern clinical oncology group performance status is 0 or 1.
5.Oral administration is possible without signs of bowel obstruction nor bleeding.
6. Adequate organ function satisfying following criteria.
WBC > 3,000/mm3
Plt > 100,000/mm3
AST < 100 IU/L
ALT < 100IU/L
T.Bil < 2.0 g/dl
Cre < 1.5mg/dl
7. Given written informed consent.
Key exclusion criteria 1. Diagnosed as dementia.
2. Psychiatric disorder including alcoholism.
3. Regular use of steroids or opioid.
4. With a history of hypersensitivity to ramelteon.
5. Treated with Fluvoxamine meleate.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Terashima Masanori
Organization Shizuoka Cancer Center
Division name Division of Gastric Surgery
Zip code
Address 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL 055-989-5222
Email m.terashima@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Honda Shinsaku
Organization Shizuoka Cancer Center
Division name Division of Gastric Surgery
Zip code
Address 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL 055-989-5222
Homepage URL
Email sh.honda@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

Funding Source
Organization Shizuoka Cancer Center
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
2015 Year 08 Month 17 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 Open public recruiting
Date of protocol fixation
2015 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 17 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
2015 Year 08 Month 17 Day
Last modified on
2016 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021458

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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