The purpose of this study is to evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis (ERE).
1. To evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis patients 2. To evaluate the safety of rebamipide as an adjuvant regimen in erosive reflux esophagitis (ERE)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
143
Oral administration of Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast
Oral administration of Mucosta (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch, and dinner
Oral administration of Mucosta®-placebo, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
Yang Shiming
Chongqing, Chongqing Municipality, China
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Kyungpook National University Medical Center
Daegu, South Korea
Konyang University Hospital
Daejeon, South Korea
Endoscopic healing rate
The ratio of the endoscopically completely healed (normal or minimal change) patients per groups
Time frame: 4 weeks
Histologic change
Histologic change defined with Hematoxylin and eosin (H\&E) stain
Time frame: 4 weeks
Change in inflammatory cytokines
Change in the tissue level of Platelet activating factor (PAF) and Interleukin-8 (IL-8)
Time frame: 4 weeks
Time to complete symptom relief
Interval between inital medication and the first time of symptom relief judged by subject's diary
Time frame: every 2 week, up to 4 week
Overall symptom relief
The proportion of relieved subjects at the end of treatment
Time frame: every 2 week, up to 4 week
Adverse events profile
patient's symptoms, physical findings, abnormal laboratory values, vital signs, and ECG findings
Time frame: every 2 week, up to 4week
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Severance Hospital, Yonsei University Health System
Seoul, South Korea