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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002369
Receipt No. R000002908
Scientific Title Clinical trial on efficacy and safety of long-term Rebamipide therapy for successful eradication of Helicobacter pylori.
Date of disclosure of the study information 2010/01/01
Last modified on 2015/06/12

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Basic information
Public title Clinical trial on efficacy and safety of long-term Rebamipide therapy for successful eradication of Helicobacter pylori.
Acronym Efficacy of rebamipide for gastritis after eradication of Helicobacter pylori.
Scientific Title Clinical trial on efficacy and safety of long-term Rebamipide therapy for successful eradication of Helicobacter pylori.
Scientific Title:Acronym Efficacy of rebamipide for gastritis after eradication of Helicobacter pylori.
Region
Japan

Condition
Condition Patients who successful eradication therapy of Helicobacter pylori.
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of our study is to investigate efficacy in long term rebamipide therapy for prevention of histological gastritis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change of histological gastritis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 treatment group receive rebamipide 300mg three times daily for 1 year.
Interventions/Control_2 control group do not receive rebamipide.
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 Patient who fills everything the following
1) Helicobacter pylori-positive patient.
2) Patient of 20 years or more
3) Early gastric cancer, planning to have endoscopic treatment.
4) Patient who gives written informed consent
Key exclusion criteria 1) Subjects with malignancy
2) Drug allergy
3) Severe complication
4) take non-steroidal inflammatory drugs
5) H. pylori eradication failure after first and second-line therapy.
6) Cases with unsuitable recognition by doctors
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Haruma
Organization Kawasaki Medical School
Division name Department of Internal Medicine, division of Gastroenterology
Zip code
Address 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan,
TEL 086-462-1111
Email tkamada@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoari Kamada
Organization Kawasaki Medical School
Division name Department of Internal Medicine, division of Gastroenterology
Zip code
Address 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan,
TEL 086-462-1111
Homepage URL
Email tkamada@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Internal Medicine, division of Gastroenterology
Kawasaki Medical School
Institute
Department

Funding Source
Organization Department of Internal Medicine, division of Gastroenterology
Kawasaki Medical School
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
2010 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially 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
2009 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2014 Year 04 Month 01 Day
Date of closure to data entry
2014 Year 04 Month 01 Day
Date trial data considered complete
2014 Year 04 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 23 Day
Last modified on
2015 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002908

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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