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

Kangdong Sacred Heart Hospital

Status: Completed

Conditions: Stomach Ulcer

Treatments: Drug: Rebamipide; Drug: pantoprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01167101

08-62

Details and patient eligibility

About

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.

Enrollment: 290 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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290 participants in 2 patient groups

Pantoprazole

Other group

Description:

controls Pantoprazole 40mg qd for 28days

Treatment:

Drug: pantoprazole

Pantoprazole + Rebamipde

Active Comparator group

Description:

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

Treatment:

Drug: pantoprazole

Drug: Rebamipide