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

• Sponsor: Kangdong Sacred Heart Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01167101
• Collaborator: (none)
• Enrollment: 290
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 15.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stomach Ulcer	Drug: Rebamipide; Drug: pantoprazole	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 290 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection? : Multicenter, Randomized, and Prospective Study
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Pantoprazole controls Pantoprazole 40mg qd for 28days	Drug: pantoprazole; pantoprazole 40mg qd for 28days
Active Comparator: Pantoprazole + Rebamipde Pantoprazole 40mg qd + Rebamipide 100mg Tid for 28days	Drug: Rebamipide; Rebamipide 100mg Tid for 28days; Drug: pantoprazole; pantoprazole 40mg qd for 28days

Outcome Measures

Primary Outcome Measures

1. Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kangdong Sacred Heart Hospital	Seoul		Korea, Republic of	134-701

Sponsors and Collaborators

• Kangdong Sacred Heart Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shin, Woon Geon, Professor, Kangdong Sacred Heart Hospital
• ClinicalTrials.gov Identifier: NCT01167101
• Other Study ID Numbers: 08-62
• First Posted: Jul 22, 2010
• Last Update Posted: Sep 4, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Shin, Woon Geon, Professor, Kangdong Sacred Heart Hospital: Rebamipide; gastric ulcer; healing rate; iatrogenic gastric ulcer after endoscopic submucosal dissection
• Additional relevant MeSH terms: Stomach Ulcer; Ulcer; Pantoprazole; Rebamipide

Study Results

No Results Posted as of Sep 4, 2015