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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-04-30

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.

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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.

Conditions

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Stomach Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Rebamipide

1. 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).
2. Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks

Group Type EXPERIMENTAL

Rebamipide

Intervention Type DRUG

1. Brand name: Mucosta® Tab.
2. Generic name: Rebamipide.
3. Chemical name:

(±)-2-(4-chlorobenzoylamino)-3-\[2(1H)-quinolinon-4-yl\]propionic acid.
4. Formulation: Tablet (White, film-coated tablet).
5. Strength: One tablet contains rebamipide 100mg.
6. Storage condition: 15℃\~25℃.
7. Manufacturer: Korea Otsuka Pharmaceuticals

Omeprazole

1. 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)
2. Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks

Group Type ACTIVE_COMPARATOR

Omeprazole

Intervention Type DRUG

1. Brand name: Losec® Cap.
2. Generic name: Omeprazole.
3. 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.

Interventions

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Rebamipide

1. Brand name: Mucosta® Tab.
2. Generic name: Rebamipide.
3. Chemical name:

(±)-2-(4-chlorobenzoylamino)-3-\[2(1H)-quinolinon-4-yl\]propionic acid.
4. Formulation: Tablet (White, film-coated tablet).
5. Strength: One tablet contains rebamipide 100mg.
6. Storage condition: 15℃\~25℃.
7. Manufacturer: Korea Otsuka Pharmaceuticals

Intervention Type DRUG

Omeprazole

1. Brand name: Losec® Cap.
2. Generic name: Omeprazole.
3. 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.

Intervention Type DRUG

Other Intervention Names

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Mucosta Losec

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No