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

NCT00272467 | Completed Phase 4 DMC

• 1 other identifier: OIAAMCTIVK205
• Study Type: interventional
• Target: 132
• Locations: 2 countries
• Sites: 7

Brief Summary

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.

Conditions

Stomach Ulcer

Keywords

Helicobacter pylori; Stomach ulcer; Rebamipide; Omeprazole

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  drug cost/effect ratio

Study Arms (2)

Rebamipide

EXPERIMENTAL

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

Drug: Rebamipide

Omeprazole

ACTIVE COMPARATOR

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

Drug: Omeprazole

Interventions

Rebamipide 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

Also known as: Mucosta

Rebamipide

Omeprazole 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.

Also known as: Losec

Omeprazole

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Otsuka International Asia Arab: lead
• Zhejiang Otsuka Pharmaceutical Co., Ltd.: collaborator
• Korea Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (7)

The 1st Affiliated hospital - Zhongshan Univ.

Guangzhou, Guangdong, 510080, China

Location

Nanfang Hospital - Nanfang Medical Univ.

Guangzhou, Guangdong, 510515, China

Location

Xijing Hospital - The 4th Military Medical Univ

Xi’an, Shanxi, 710032, China

Location

The 1st Affiliated Hospital - Medical School of Zhejiang Univ.

Hangzhou, Zhejiang, 310003, China

Location

Ren-Ji Hospital - Shanghai Second Medical Univ.

Shanghai, 200001, China

Location

Korea University Ansan Hospital

Ansan, 425-707, South Korea

Location

Severance Hospital, Seoul National University

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Stomach Ulcer

Interventions

rebamipide; Omeprazole

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jin-Ho Kim, M.D.

  Asan Medical Center, Ulsan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2006
• First Posted: January 6, 2006
• Study Start: July 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

KR (2); CN (5)