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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011401
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Fukushima Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013303

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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