UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of rebamipide for human gastric membrane after distal gastrectomy
Title of the study (Brief title)	rebamipide trial for gastritis after distal gastrectomy
Region	Japan

Condition
Condition	Gastritis in remnant stomach
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To avoid gastritis in remnant stomach, rebamipide will protect the inflammatory change of the membrane.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Patient number with gastritis or inflammatory change in remnant stomach
Key secondary outcomes	Loss of body weight

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Rebamipide 300mg per day for a year
Interventions/Control_2	No treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient who underwent distal gastrectomy
Key exclusion criteria	1.Patients treated with gastric secretion inhibitor in a month prior to this study. 2.Patients with thoracotomy, hepatectomy, pancreatomy or colectomy. 3.Patients with other malignancy. 4.Patients with cardiac, hepatic or hematologic disease.
Target sample size	20

Research contact person
Name of lead principal investigator	Hisahiro Matsubara
Organization	Chiba University Graduate School of Medicine
Division name	Frontier Surgery
Address	1-8-1, Inohana, Chuouku,Chiba
TEL	043-222-7171
Email	hk@faculty.chiba-u.jp

Public contact
Name of contact person	Hiroshi Kawahira
Organization	Chiba University Graduate School of Medicine
Division name	Frontier Surgery
Address	1-8-1, Inohana, Chuouku,Chiba
TEL	043-222-7171
Homepage URL
Email	hk@faculty.chiba-u.jp

Sponsor
Institute	Chiba University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Scholarship donation
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	2009 Year 06 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 04 Month 20 Day
Anticipated trial start date	2009 Year 05 Month 01 Day
Last follow-up date	2012 Year 04 Month 01 Day
Date of closure to data entry	2012 Year 05 Month 01 Day
Date trial data considered complete
Date analysis concluded	2016 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 06 Month 11 Day
Last modified on	2016 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002522