Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy
Stomach Ulcer
About this trial
This is an interventional treatment trial for Stomach Ulcer focused on measuring Helicobacter pylori, Stomach ulcer, Rebamipide, Omeprazole
Eligibility Criteria
Inclusion Criteria: Patients aged 20 or older at the time of writing the informed consent H. pylori-positive patient. Patients who are diagnosed with gastric ulcer by endoscopy and have the following ulcer characteristics; Non-scarring ulcer (stage A1, A2, H1, H2 according to the Sakita-Miwa classification), Single ulcer, Ulcer size of 5 to 20mm in diameter Exclusion Criteria: Patients who previously underwent H. pylori eradication therapy Malignant gastric ulcer Linear ulcer Patients with history of upper GI tract resection or vagotomy Patients with continuous NSAIDs use within 4 weeks prior to study initiation Patients with ulcer complications including perforation or pyloric stenosis Gastric ulcer prone to bleeding (e.g. exposed blood vessels at ulcer base) Patients with infectious mononucleosis Patients with known hypersensitivity to penicillin, clarithromycin, omeprazole, amoxicillin or rebamipide Patients on medications such as terfenadine or pimozide which are contraindicated with clarithromycin usage Pregnant or possibly pregnant women, lactating women, or those with a plan to conceive during this study Blood test results of Hb ≤ 8.0 g/dl, platelet ≤50,000 /㎕, total WBC ≤ 4000/㎕ or ≥ 10,000/㎕, and with serum test results showing the levels of AST, ALT, ALP, LDH, BUN, and creatinine exceeding twice the normal range of respective institution. Other patients deemed not eligible for this study by investigators
Sites / Locations
- The 1st Affiliated hospital - Zhongshan Univ.
- Nanfang Hospital - Nanfang Medical Univ.
- Xijing Hospital - The 4th Military Medical Univ
- The 1st Affiliated Hospital - Medical School of Zhejiang Univ.
- Ren-Ji Hospital - Shanghai Second Medical Univ.
- Korea University Ansan Hospital
- Severance Hospital, Seoul National University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Rebamipide
Omeprazole
Dosage (1) The eradication therapy period (for all cases) Amoxicillin 2,000mg/day, clarithromycin 1,000 mg/day and omeprazole 40 mg/day. b.i.d. (morning and evening), oral administration. (2) The ulcer treatment period (on a double-blind basis) Rebamipide 100mg, t.i.d. (before breakfast, evening, before bed). Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks
Dosage (1) The eradication therapy period (for all cases) Amoxicillin 2,000mg/day, clarithromycin 1,000 mg/day and omeprazole 40 mg/day. b.i.d. (morning and evening), oral administration. (2) The ulcer treatment period (on a double-blind basis) omeprazole 20mg, once daily (before breakfast) Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks