UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018697 |
|---|---|
| Receipt number | 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 19:56:52 |
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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
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
sh.honda@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021458
