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

This study has been completed.
Sponsor:
Collaborators:
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:
Korea Otsuka International Asia Arab
ClinicalTrials.gov Identifier:
NCT00272467
First received: January 4, 2006
Last updated: December 15, 2009
Last verified: December 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov Identifier: NCT00272467     History of Changes
Other Study ID Numbers: OIAAMCTIVK205
Study First Received: January 4, 2006
Last Updated: December 15, 2009
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:
Ulcer
Stomach Ulcer
Pathologic Processes
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Omeprazole
Rebamipide
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014