UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003181 |
|---|---|
| Receipt number | 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 12:41:40 |
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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
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
in2038@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003858
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
