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

Otsuka

Status and phase: Completed; Phase 4

Conditions: Stomach Ulcer

Treatments: Drug: Omeprazole; Drug: Rebamipide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00272467

OIAAMCTIVK205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

Rebamipide

Experimental group

Description:

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

Treatment:

Drug: Rebamipide

Omeprazole

Active Comparator group

Description:

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

Treatment:

Drug: Omeprazole