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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shin, Woon Geon, Kangdong Sacred Heart Hospital
ClinicalTrials.gov Identifier:
NCT01167101
First received: July 20, 2010
Last updated: September 3, 2015
Last verified: September 2015

July 20, 2010
September 3, 2015
May 2009
December 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01167101 on ClinicalTrials.gov Archive Site
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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
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.
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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Stomach Ulcer
  • Drug: Rebamipide
    Rebamipide 100mg Tid for 28days
  • Drug: pantoprazole
    pantoprazole 40mg qd for 28days
  • Pantoprazole
    controls Pantoprazole 40mg qd for 28days
    Intervention: Drug: pantoprazole
  • Active Comparator: Pantoprazole + Rebamipde
    Pantoprazole 40mg qd + Rebamipide 100mg Tid for 28days
    Interventions:
    • Drug: Rebamipide
    • Drug: pantoprazole
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
290
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01167101
08-62
Yes
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Shin, Woon Geon, Kangdong Sacred Heart Hospital
Kangdong Sacred Heart Hospital
Not Provided
Not Provided
Kangdong Sacred Heart Hospital
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP