UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001740
Receipt No. R000002060
Scientific Title The healing effect of rebamipide for artificial ulcer after treatment of endoscopic submucosal dissection: a prospective randomized trial
Date of disclosure of the study information 2009/02/27
Last modified on 2012/03/06

* 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 The healing effect of rebamipide for artificial ulcer after treatment of endoscopic submucosal dissection: a prospective randomized trial
Acronym Rebamipide treatment after ESD
Scientific Title The healing effect of rebamipide for artificial ulcer after treatment of endoscopic submucosal dissection: a prospective randomized trial
Scientific Title:Acronym Rebamipide treatment after ESD
Region
Japan

Condition
Condition Early gastric cancer, Gastric adenoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examination of the healing effect of rebamipide for artificial ulcer after ESD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The healing ratio of artificial ulcer at 4weeks after ESD.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of PPI(proton pump inhibitor) plus rebamipide 300mg for 8weeks
Interventions/Control_2 Administration of PPI for 8weeks after ESD
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 The patients of adenocarcinoma and early gastric cancer who receive ESD.
Key exclusion criteria The patients who: (1)repeat hematemesis, (2) pregnant, (3)has sever liver, renal and cardiopulumonary disease, (4)has allergic drug reaction.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Araki, M.D.,Ph.D.
Organization Gifu University
Division name Department of Gastroenterology
Zip code
Address 1-1Yanagito, Gifu city, Gifu prefecture,Japan, 501-1194
TEL 058-230-6308
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Gifu University
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email araara@gifu-u.ac.jp

Sponsor
Institute Department of Gastroenterology, Gifu University
Institute
Department

Funding Source
Organization Department of Gastroenterology, Gifu 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
2009 Year 02 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

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
2008 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2011 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 02 Month 27 Day
Last modified on
2012 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002060

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.