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

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

Overview[ - collapse ][ - ]

Purpose	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	Stomach Ulcer
Intervention	Drug: Rebamipide Drug: pantoprazole
Phase	N/A
Sponsor	Kangdong Sacred Heart Hospital
Responsible Party	Kangdong Sacred Heart Hospital
ClinicalTrials.gov Identifier	NCT01167101
First Received	July 20, 2010
Last Updated	July 22, 2010
Last verified	May 2010

Tracking Information[ + expand ][ + ]

First Received Date	July 20, 2010
Last Updated Date	July 22, 2010
Start Date	May 2009
Estimated Primary Completion Date	October 2010
Current Primary Outcome Measures	Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer [Time Frame: at 2month after endoscopic submucosal dissection (ESD)] [Designated as safety issue: No]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.
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection?
Official Title	Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection? : Multicenter, Randomized, and Prospective Study
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Condition	Stomach Ulcer
Intervention	Drug: Rebamipide Rebamipide 100mg Tid for 28days Drug: pantoprazole pantoprazole 40mg qd for 28days
Study Arm (s)	No Intervention: Pantoprazole controls Pantoprazole 40mg qd for 28days Active Comparator: Pantoprazole + Rebamipde Pantoprazole 40mg qd + Rebamipide 100mg Tid for 28days

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	310
Estimated Completion Date	October 2010
Estimated Primary Completion Date	August 2010
Eligibility Criteria	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
Gender	Both
Ages	20 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Woon Geon Shin, MD 82-2-2225-2814 sgun91@medimail.co.kr
Location Countries	Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT01167101
Other Study ID Numbers	08-62
Has Data Monitoring Committee	Yes
Information Provided By	Kangdong Sacred Heart Hospital
Study Sponsor	Kangdong Sacred Heart Hospital
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	May 2010

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