Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy
Information source: Korea Otsuka International Asia Arab
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stomach Ulcer
Intervention: Rebamipide (Drug); Omeprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Korea Otsuka International Asia Arab Official(s) and/or principal investigator(s): Jin-Ho Kim, M.D., Principal Investigator, Affiliation: Asan Medical Center, Ulsan University
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.
Clinical Details
Official title: A Comparative Study on the Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Gastric ulcer healing rate
Secondary outcome: 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
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
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Ren-Ji Hospital - Shanghai Second Medical Univ., Shanghai 200001, China
Korea University Ansan Hospital, Ansan 425-707, Korea, Republic of
Severance Hospital, Seoul National University, Seoul 120-752, Korea, Republic of
Nanfang Hospital - Nanfang Medical Univ., Guangzhou, Guangdong 510515, China
The 1st Affiliated hospital - Zhongshan Univ., Guangzhou, Guangdong 510080, China
Xijing Hospital - The 4th Military Medical Univ, Xi'An, Shanxi 710032, China
The 1st Affiliated Hospital - Medical School of Zhejiang Univ., Hangzhou, Zhejiang 310003, China
Additional Information
Starting date: July 2005
Last updated: April 27, 2015
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