UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The anti-inflammatory and organ protective effect of Teprenone
Title of the study (Brief title)	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	Yuko Nakano
Organization	Fukushima Medical University
Division name	Department of Anesthesiolosy
Address	1 Hikarigaoka, Fukushima-City, Fukushima-Pref, Japan
TEL
Email

Public contact
Name of contact person
Organization	Fukushima Medical University
Division name	Department of Anesthesiolosy
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000013303