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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stomach Ulcer

Intervention / Treatment
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* Drug: Rebamipide
* Drug: Omeprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rebamipide<br>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 | Drug: Rebamipide<br>* Brand name: Mucosta® Tab. Generic name: Rebamipide. Chemical name: (±)-2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-yl]propionic acid. Formulation: Tablet (White, film-coated tablet). Strength: One tablet contains rebamipide 100mg. Storage condition: 15℃ 25℃. Manufacturer: Korea Otsuka Pharmaceuticals<br>* Other names: Mucosta;|
| Active Comparator: Omeprazole<br>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 | Drug: Omeprazole<br>* Brand name: Losec® Cap. Generic name: Omeprazole. 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.<br>* Other names: Losec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 12 weeks after the initial administration of the study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric ulcer healing rate in cases with successful H.pylori eradication and H.pylori eradication failure (12 weeks after administration of the study medication.) |  | at 12 weeks after the initial administration of the study medication | 
| Serum gastrin level |  | 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. | drug cost/effect ratio | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Stomach ulcer, Rebamipide, Omeprazole