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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01167101
Enrollment
290
Registered
2010-07-22
Start date
2009-05-31
Completion date
2010-12-31
Last updated
2015-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach Ulcer

Keywords

Rebamipide, gastric ulcer, healing rate, iatrogenic gastric ulcer after endoscopic submucosal dissection

Brief summary

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.

Interventions

DRUGRebamipide

Rebamipide 100mg Tid for 28days

DRUGpantoprazole

pantoprazole 40mg qd for 28days

Sponsors

Kangdong Sacred Heart Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcerat 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026