UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013235 |
|---|---|
| Receipt number | R000015379 |
| Scientific Title | An exploratory study of the efficacy and safety of yokukansan for postoperative delirium in patients who underwent surgical resection of malignant tumor of digestive system. |
| Date of disclosure of the study information | 2014/02/26 |
| Last modified on | 2018/09/18 11:28:43 |
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Basic information
Public title
An exploratory study of the efficacy and safety of yokukansan for postoperative delirium in patients who underwent surgical resection of malignant tumor of digestive system.
Acronym
A clinical study of yokukansan in patients with postoperative delirium after surgical resection of malignant tumor of digestive system.
Scientific Title
An exploratory study of the efficacy and safety of yokukansan for postoperative delirium in patients who underwent surgical resection of malignant tumor of digestive system.
Scientific Title:Acronym
A clinical study of yokukansan in patients with postoperative delirium after surgical resection of malignant tumor of digestive system.
Region
| Japan |
Condition
Condition
Digestive system cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the inhibition effect and safety of yokukansan for onset of postoperative delirium in elderly.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of postoperative delirium
Key secondary outcomes
Postoperative length of stay in the hospital
Severity of symptoms of delirium
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
yokukansan administering group(7.5mg/day)
Interventions/Control_2
yokukansan non-administering group (0mg/day)
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) Patients who scheduled surgical resection of malignant tumor of digestive system.
2) Patients who can be administered drugs orally.
3) Patients who give written informed consent to participate in the study
Key exclusion criteria
1) Patients who require emergency surgery.
2)Patients with severe complications, including cardiac, renal, blood or lung diseases, or with other complications judged to be life-threatening.
3)Patients administered antipsychotic agents and therapeutic agents for dementia.
4)Patients administered Kampo medicines other than the study drug.
5) Patients who were judged to be inappropriate as subjects by the study investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsunehiko Maruyama |
Organization
Hitachi,Ltd.,Hitachi General Hospital
Division name
Surgery
Zip code
Address
2-1-1,Jonann-cho,Hitachi-si,Ibaraki-Ken,Japan
TEL
0294-23-1111
tsunehiko.maruyama.kq@hitachi.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayo Okawa |
Organization
Hitachi,Ltd.,Hitachi General Hospital
Division name
clinical research center
Zip code
Address
2-1-1,Jonann-cho,Hitachi-si,Ibaraki-Ken,Japan
TEL
0294-23-1111
Homepage URL
masayo.okawa.ne@hitachi.com
Sponsor or person
Institute
Hitachi,Ltd.,Hitachi General Hospital
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
株式会社日立製作所 日立総合病院(茨城県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 24 | Day |
Last modified on
| 2018 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015379
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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