UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001815
Receipt No. R000001929
Scientific Title Prospective randomized controlled study for preventive effect of menatetrenone against the recurrence of hepatocellular carcinoma after hepatectomy
Date of disclosure of the study information 2009/03/30
Last modified on 2010/04/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective randomized controlled study for preventive effect of menatetrenone against the recurrence of hepatocellular carcinoma after hepatectomy
Acronym Preventive effect of menatetrenone against recurrence of hepatocellular carcinoma
Scientific Title Prospective randomized controlled study for preventive effect of menatetrenone against the recurrence of hepatocellular carcinoma after hepatectomy
Scientific Title:Acronym Preventive effect of menatetrenone against recurrence of hepatocellular carcinoma
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess whether menatetrenone suppresses the recurrence of hepatocellular carcinoma in patients undergo surgical resection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Disease-free survival period after hepatectomy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The study was designed to test the hypothesis that MNT would reduce the incidence of recurrence of HCC in patients underwent initial hepatectomy.
The patients stated to take 15 mg of menatetrenone, 3 times a day, orally everyday.
Interventions/Control_2 Control group does not take any drugs.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergo curative hepatectomy at the Second Department of Surgery, Dokkyo Medical University.
Key exclusion criteria Patients who take warfarin or other vitamin K analogs.
Target sample size 84

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichi Kubota
Organization Dokkyo Medical University
Division name Second Department of Surgery
Zip code
Address Kitakobayashi 880, Mibu, Shimotsuga, Tochigi
TEL 0282-86-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tokihiko Sawada
Organization Dokkyo Medical University
Division name Second Department of Surgery
Zip code
Address Kitakobayashi 880, Mibu, Shimotsuga, Tochigi
TEL 0282-86-1111
Homepage URL
Email tsawada@dokkyomed.ac.jp

Sponsor
Institute Second Department of Surgery
Dokkyo Medical University
Institute
Department

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
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
2009 Year 03 Month 30 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 No longer recruiting
Date of protocol fixation
2005 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2005 Year 11 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 03 Month 30 Day
Last modified on
2010 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001929

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.