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

Stomach Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167101
• Other study ID #: 08-62
• Status: Completed
• Phase: N/A
• First received: July 20, 2010
• Last updated: September 3, 2015
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: September 2015
• Source: Kangdong Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Ulcer
• Ulcer

Intervention

Drug:
• Rebamipide
Rebamipide 100mg Tid for 28days
• pantoprazole
pantoprazole 40mg qd for 28days

Locations

Country	Name	City	State
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangdong Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer	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.	at 2month after endoscopic submucosal dissection (ESD)	No