Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-12-31

Brief Summary

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Treatment strategy of post endoscopic submucosal dissection (ESD) ulcer is not yet conclusive. Rebamipide is a mucosal protective agent widely used in East Asia and has good effect on quality of ulcer healing (QOUH). The investigators will conduct this randomized controlled study to assess the effect of a combination therapy of rebamipide and proton pump inhibitor (PPI) on post ESD ulcer healing.

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Detailed Description

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Conditions

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Stomach Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Pantoprazole

controls Pantoprazole 40mg qd for 28days

Group Type OTHER

pantoprazole

Intervention Type DRUG

pantoprazole 40mg qd for 28days

Pantoprazole + Rebamipde

Pantoprazole 40mg qd + Rebamipide 100mg Tid for 28days

Group Type ACTIVE_COMPARATOR

Rebamipide

Intervention Type DRUG

Rebamipide 100mg Tid for 28days

pantoprazole

Intervention Type DRUG

pantoprazole 40mg qd for 28days

Interventions

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Rebamipide

Rebamipide 100mg Tid for 28days

Intervention Type DRUG

pantoprazole

pantoprazole 40mg qd for 28days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients underwent ESD for gastric adenoma or cancer

Exclusion Criteria

* subjects with previous gastric surgery
* subjects taking aspirin, anticoagulant, or antiplatelet agent
* subjects having malignancy except gastric cancer
* pregnant or breast-feeding women

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No