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

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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Key information

Conditions

Stomach Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangdong Sacred Heart Hospital

Seoul, 134-701, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rebamipide

Drug

Rebamipide 100mg Tid for 28days

Pantoprazole

Drug

pantoprazole 40mg qd for 28days

Primary outcomes

Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer

Time frame: at 2month after endoscopic submucosal dissection (ESD)

Healing efficacy will be assessed by the change of ulcer size. Quality of Ulcer Healing(QOUH) wil be assessed by nodularity in the healed ulcer by two endoscopist.

Sponsors and collaborators

Lead sponsor

Kangdong Sacred Heart Hospital

Other

Registry information

Official study title

Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection? : Multicenter, Randomized, and Prospective Study

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jul 22, 2010
Registry last updated: Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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