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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003181
Receipt No. R000003858
Scientific Title Comparison of Helicobacter pylori Eradication plus Rebamipide combination therapy with proton pump inhibitor(PPI) alone in the treatment of endoscopic submucosal dissection(ESD) induced ulcers in H.pylori positive eary gastric cancer: Prospective Randomized Pilot Syudy
Date of disclosure of the study information 2010/02/14
Last modified on 2012/12/03

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Basic information
Public title Comparison of Helicobacter pylori Eradication plus Rebamipide combination therapy with proton pump inhibitor(PPI) alone in the treatment of endoscopic submucosal dissection(ESD) induced ulcers in H.pylori positive eary gastric cancer: Prospective Randomized Pilot Syudy
Acronym Helicobacter pylori Eradication plus Rebamipide promotes gastric ulcer healing after Endoscopic Submucosal Dissection(ESD): Prospective Randomized Pilot Syudy
Scientific Title Comparison of Helicobacter pylori Eradication plus Rebamipide combination therapy with proton pump inhibitor(PPI) alone in the treatment of endoscopic submucosal dissection(ESD) induced ulcers in H.pylori positive eary gastric cancer: Prospective Randomized Pilot Syudy
Scientific Title:Acronym Helicobacter pylori Eradication plus Rebamipide promotes gastric ulcer healing after Endoscopic Submucosal Dissection(ESD): Prospective Randomized Pilot Syudy
Region
Japan

Condition
Condition H.pylori positive eary gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the curative efficacy of H.pylori eradication plus rebamipide after endoscopic submucosal dissection induced ulcers in H.pylori positive early gastric cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Endoscopic evaluations:The primary endopoint is the ulcer healing(S1, S2) at 8 weeks after ESD.
Key secondary outcomes Endoscopic evaluations:ulcer healing rate
Symptom
Incidence of asynchronous multiple cancer
Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients in the treatment group receive H.pylori eradication therapy(Omeprazole 40 mg/day, clarithromycin 800 mg/day, amoxicillin 1500 mg/day) for 7 days and then rebamipide (300 mg/day) for 7 weeks.
Interventions/Control_2 Patients in the control group do not receive rebamipide. Omeprazole (20 mg/day) receive for 8 weeks.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)The patient provided written informed consents to participate in this study.
2)H.pylori positive patient
3)The lesion is to be resected en bloc by ESD.
4)The invasion depth of carcinoma is diagnosed as mucosa endoscopically.
5)It is onset and one-shot(in principle) gastric cancer.
6)The patient without therapeutic medical history for other organ carcinoma.
7)Age is equal to or less than 75 years old more than 20 years old.
8)Sexuality no object.
Key exclusion criteria 1)The patient with past H.pylori eradication treatment
2)The patient who coexists for active gastroduodenal ulcer
3)Upper gastrointestinal tract ablative operation and the patient with medical history of vagotomy
4)The patient who does not become a subject of medical treatment for perforation/pyloric stenosis, a massive bleeding case.
5)The patient who could not interrupt the antiplatelet agent or anticoagulant temporarily for ESD therapy.
6)The patient with medical history of shock by amoxicillin.
7)The patient with glandular infection.
8)The patient with anaphylactic medical history for penicillin antimicrobial agent, clarithromycin, a proton pump inhibitor and rebamipide.
9)The patient who is administrated drug considered to be contraindication of clarithromycin(terfenadine, cisapride, pimoside).
10)The patient with grave complication(respiratory tract disease, kidney disease, treatment by use of insulin or diabetes mellitus inadequate control) and a hindrance for examination enforcement.
11)Inadequate to entry judged by investigators.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhide Higuchi
Organization Osaka Medical College
Division name Second Department of Internal Medicine
Zip code
Address 2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL 072-683-1221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Umegaki
Organization Osaka Medical College
Division name Second Department of Internal Medicine
Zip code
Address 2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL 072-683-1221
Homepage URL
Email in2038@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor Osaka City University
Osaka Medical Center for Cancer and Cardiovascular Diseases
Kyoto Prefectural University of Medicine
Kobe University
Nara Medical University
Wakayama Medical University
etc.
Name of secondary funder(s) None

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 大阪医科大学付属病院(大阪府)
大阪市立大学付属病院(大阪府)
大阪府立成人病センター(大阪府)
北野病院(大阪府)
京都府立医科大学付属病院(京都府)
神戸大学付属病院(兵庫県)
高槻赤十字病院(大阪府)
奈良県立医科大学付属病院(奈良県)
和歌山県立医科大学付属病院(和歌山県)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 14 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 Completed
Date of protocol fixation
2010 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 14 Day
Last modified on
2012 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003858

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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