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

NCT01167101 | Completed DMC

• 1 other identifier: 08-62
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Ulcer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Pantoprazole

OTHER

controls Pantoprazole 40mg qd for 28days

Drug: pantoprazole

Pantoprazole + Rebamipde

ACTIVE COMPARATOR

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

Drug: Rebamipide; Drug: pantoprazole

Interventions

Rebamipide DRUG

Rebamipide 100mg Tid for 28days

Pantoprazole + Rebamipde

pantoprazole DRUG

pantoprazole 40mg qd for 28days

Pantoprazole; Pantoprazole + Rebamipde

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients underwent ESD for gastric adenoma or cancer

You may not qualify if:

• subjects with previous gastric surgery
• subjects taking aspirin, anticoagulant, or antiplatelet agent
• subjects having malignancy except gastric cancer
• pregnant or breast-feeding women

Sponsors & Collaborators

• Kangdong Sacred Heart Hospital: lead

Study Sites (1)

Kangdong Sacred Heart Hospital

Seoul, 134-701, South Korea

Location

Related Publications (1)

• Shin WG, Kim SJ, Choi MH, Kim KO, Jang HJ, Park CH, Baek IH, Kim KH, Baik GH, Kae SH, Kim JH, Kim HY. Can rebamipide and proton pump inhibitor combination therapy promote the healing of endoscopic submucosal dissection-induced ulcers? A randomized, prospective, multicenter study. Gastrointest Endosc. 2012 Apr;75(4):739-47. doi: 10.1016/j.gie.2011.11.004. Epub 2012 Jan 26.

  PMID: 22281110 DERIVED

MeSH Terms

Conditions

Stomach Ulcer

Interventions

rebamipide; Pantoprazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 22, 2010
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

KR (1)