UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011401 |
|---|---|
| Receipt number | R000013303 |
| Scientific Title | The anti-inflammatory and organ protective effect of Teprenone |
| Date of disclosure of the study information | 2013/08/15 |
| Last modified on | 2018/09/12 14:32:40 |
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Basic information
Public title
The anti-inflammatory and organ protective effect of Teprenone
Acronym
The anti-inflammatory and organ protective effect of Teprenone
Scientific Title
The anti-inflammatory and organ protective effect of Teprenone
Scientific Title:Acronym
The anti-inflammatory and organ protective effect of Teprenone
Region
| Japan |
Condition
Condition
perioperative patient(malignant tumor, rheumatism, maitenance dyalisis, administration of steroids are excluded)
Classification by specialty
| Anesthesiology | Operative medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Renal or hepatic disfunction can occur after surgical operation caused by operative invasion, administration of perioperative drugs, and changing of hemodynamics. Teprenon has been used clinicalliy as anti-ulcer drugs for 20 years or more. Recently, Teprenon showed an induction of heat shock protein 70, and excerted cytoprotective and anti-inflammatory effects on various cells and tissues like liver, kidney, lung, heart, and brain. But there are few clinical studies on human. Our study can reveal the perioperative protective effect on multiple organ of Teperenon in human.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum CRP, WBC, AST, ALT, BUN, Crea, IL-6, IL-8 and TNF-alpha of blood sample in pre operation, post operation, 1,3 and 6th day after operation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Teprenone
Interventions/Control_2
Control(No medication)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
peri operative patient
Key exclusion criteria
maintenance hemodyalisis, malignant tumor, administration of steroids, rheumatism
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Nakano |
Organization
Fukushima Medical University
Division name
Department of Anesthesiolosy
Zip code
Address
1 Hikarigaoka, Fukushima-City, Fukushima-Pref, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Fukushima Medical University
Division name
Department of Anesthesiolosy
Zip code
Address
Hikarigaoka, Fukushima-City, Fukushima-Pref, Japan
TEL
Homepage URL
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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
| 2013 | Year | 08 | Month | 15 | 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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 15 | 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
| 2013 | Year | 08 | Month | 07 | Day |
Last modified on
| 2018 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013303
