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

Condition(s) targeted: Stomach Ulcer

Intervention: Rebamipide (Drug); Omeprazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Korea Otsuka International Asia Arab

Official(s) and/or principal investigator(s):
Jin-Ho Kim, M.D., Principal Investigator, Affiliation: Asan Medical Center, Ulsan University

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.

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

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

Primary outcome: Gastric ulcer healing rate (12 weeks after administration of the study medication.)

Secondary outcome:

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

Detailed description: 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.

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Ren-Ji Hospital - Shanghai Second Medical Univ., Shanghai 200001, China

Severance Hospital, Seoul National University, Seoul 120-752, Korea, Republic of

Korea University Ansan Hospital, Ansan 425-707, Korea, Republic of

The 1st Affiliated hospital - Zhongshan Univ., Guangzhou, Guangdong Province 510080, China

Nanfang Hospital - Nanfang Medical Univ., Guangzhou, Guangdong Province 510515, China

Xijing Hospital - The 4th Military Medical Univ, Xi'An, Shanxi Province 710032, China

The 1st Affiliated Hospital - Medical School of Zhejiang Univ., Hangzhou, Zhejiang Province 310003, China

Starting date: July 2005
Ending date: February 2008
Last updated: May 8, 2008