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

This study has been completed.

First Received: January 4, 2006 Last Updated: December 15, 2009 History of Changes

Sponsor:	Korea Otsuka International Asia Arab
Collaborators:	Zhejiang Otsuka Pharmaceutical Co., Ltd. Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:	Korea Otsuka International Asia Arab
ClinicalTrials.gov Identifier:	NCT00272467

Purpose

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.

Condition	Intervention	Phase
Stomach Ulcer	Drug: Rebamipide Drug: Omeprazole	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Comparative Study on the Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy

Resource links provided by NLM:

Drug Information available for: Omeprazole Omeprazole magnesium Rebamipide Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Korea Otsuka International Asia Arab:

Primary Outcome Measures:

Gastric ulcer healing rate (12 weeks after administration of the study medication.)

Secondary Outcome Measures:

Gastric ulcer healing rate in cases with successful H.pylori eradication and H.pylori eradication failure (12 weeks after administration of the study medication.)
Serum gastrin level
Economical efficiency

Enrollment:	132
Study Start Date:	July 2005
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272467

Locations

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

Sponsors and Collaborators

Korea Otsuka International Asia Arab

Zhejiang Otsuka Pharmaceutical Co., Ltd.

Korea Otsuka Pharmaceutical Co.,Ltd.

Investigators

Principal Investigator:

Jin-Ho Kim, M.D.

Asan Medical Center, Ulsan University

More Information

No publications provided

Study ID Numbers:	OIAAMCTIVK205
Study First Received:	January 4, 2006
Last Updated:	December 15, 2009
ClinicalTrials.gov Identifier:	NCT00272467 History of Changes
Health Authority:	Korea: Institutional Review Board; China: Institutional Review Board

Keywords provided by Korea Otsuka International Asia Arab:

Helicobacter pylori
Stomach ulcer
Rebamipide
Omeprazole

Additional relevant MeSH terms:

Stomach Ulcer
Antioxidants
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Ulcer
Physiological Effects of Drugs
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors

Protective Agents
Rebamipide
Pharmacologic Actions
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Therapeutic Uses
Anti-Ulcer Agents
Peptic Ulcer

ClinicalTrials.gov processed this record on February 09, 2010