Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea Otsuka International Asia Arab
• Collaborators: Korea Otsuka Pharmaceutical Co., Ltd.; Zhejiang Otsuka Pharmaceutical Co., Ltd.
• Treatments: Omeprazole; Rebamipide

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