The purpose of this study is to evaluate the ulcer healing efficacy of rebamipide in comparison with omeprazole in Helicobacter pylori-positive gastric ulcer after eradication therapy.
This study is designed to evaluate the ulcer healing efficacy of rebamipide administered following the eradication therapy in comparison with the well known PPI, omeprazole. This is a double-blind, comparative study which is expected to prove the role of rebamipide in gastric ulcer healing after the eradication therapy. This study may contribute to further clinical research on a new type of ulcer treatment by looking at the treatment modality based on the enhancement of defensive factors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
132
1. Brand name: Mucosta® Tab. 2. Generic name: Rebamipide. 3. Chemical name: (±)-2-(4-chlorobenzoylamino)-3-\[2(1H)-quinolinon-4-yl\]propionic acid. 4. Formulation: Tablet (White, film-coated tablet). 5. Strength: One tablet contains rebamipide 100mg. 6. Storage condition: 15℃\~25℃. 7. Manufacturer: Korea Otsuka Pharmaceuticals
1. Brand name: Losec® Cap. 2. Generic name: Omeprazole. 3. Chemical name: 5-melthoxy-2-{{{4-melthoxy-3.5-dlmethyl2-pyridinyl}methyl}sulp- hinyl}-1H-benzimidazole sodium. 4) Formulation: Capsule. 5) Strength: One capsule contains omeprazole 20mg. 6) Storage condition: 15℃\~25℃. 7) Manufacturer: AstraZenaca Korea.
The 1st Affiliated hospital - Zhongshan Univ.
Guangzhou, Guangdong, China
Nanfang Hospital - Nanfang Medical Univ.
Guangzhou, Guangdong, China
Xijing Hospital - The 4th Military Medical Univ
Xi’an, Shanxi, China
The 1st Affiliated Hospital - Medical School of Zhejiang Univ.
Hangzhou, Zhejiang, China
Gastric ulcer healing rate
Rebamipide showed 81.5\~87.8% of gastric ulcer healing rate which was not inferior to 82.5\~87.8% healing rate of Omeprazole.
Time frame: at 12 weeks after the initial administration of the study medication
Gastric ulcer healing rate in cases with successful H.pylori eradication and H.pylori eradication failure (12 weeks after administration of the study medication.)
Time frame: at 12 weeks after the initial administration of the study medication
Serum gastrin level
Time frame: at 8 and 12 weeks after the initial administration of study medication
Economical efficiency
Rebamipide was more cost effective than Omeparzole for 7 weeks of gastric ulcer treatment.
Time frame: drug cost/effect ratio
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Ren-Ji Hospital - Shanghai Second Medical Univ.
Shanghai, China
Korea University Ansan Hospital
Ansan, South Korea
Severance Hospital, Seoul National University
Seoul, South Korea