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

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 Overview

• Status: Completed
• Conditions: Stomach Ulcer
• Intervention / Treatment: Drug: Rebamipide; Drug: Omeprazole

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200001
    • Ren-Ji Hospital - Shanghai Second Medical Univ.
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The 1st Affiliated hospital - Zhongshan Univ.
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital - Nanfang Medical Univ.
  • Shanxi
    • Xi'An, Shanxi, China, 710032
      • Xijing Hospital - The 4th Military Medical Univ
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The 1st Affiliated Hospital - Medical School of Zhejiang Univ.
• Korea, Republic of
  • Ansan, Korea, Republic of, 425-707
    • Korea University Ansan Hospital
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital, Seoul National University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rebamipide; 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; 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; Other Names: Mucosta
Active Comparator: Omeprazole; 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; 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.; Other Names: Losec

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Korea Otsuka International Asia Arab
• Collaborators: Korea Otsuka Pharmaceutical Co., Ltd.; Zhejiang Otsuka Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Jin-Ho Kim, M.D., Asan Medical Center, Ulsan University

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: January 4, 2006
• First Submitted That Met QC Criteria: January 4, 2006
• First Posted (Estimate): January 6, 2006

Study Record Updates

• Last Update Posted (Estimate): April 29, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Omeprazole; Stomach ulcer; Rebamipide
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Ulcer; Stomach Ulcer; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Protective Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Antioxidants; Omeprazole; Rebamipide
• Other Study ID Numbers: OIAAMCTIVK205