Official Title: “A Comparative Study on the Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-Positive Gastric Ulcer After Eradication Therapy”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Rebamipide
• Drug: Omeprazole

Primary Measures

• Gastric ulcer healing rate (12 weeks after administration of the study medication.)

Secondary Measures

• Gastric ulcer healing rate in cases with successful H.pylori eradication and H.pylori eradication failure (12 weeks after administration of the study medication.)
• Serum gastrin level
• Economical efficiency

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Korea Otsuka International Asia Arab

Overall Clinical Trial Officials and Contacts

Jin-Ho Kim, M.D. Principal Investigator Asan Medical Center, Ulsan University  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00272467

Study ID Number: OIAAMCTIVK205

ClinicalTrials.gov Identifier: NCT00272467

Health Authority: Korea: Institutional Review Board