Status:
COMPLETED
Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy
Lead Sponsor:
Korea Otsuka International Asia Arab
Collaborating Sponsors:
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Korea Otsuka Pharmaceutical Co., Ltd.
Conditions:
Stomach Ulcer
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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.
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, co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00272467
Start Date
July 1 2005
End Date
April 1 2008
Last Update
April 29 2015
Active Locations (7)
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1
The 1st Affiliated hospital - Zhongshan Univ.
Guangzhou, Guangdong, China, 510080
2
Nanfang Hospital - Nanfang Medical Univ.
Guangzhou, Guangdong, China, 510515
3
Xijing Hospital - The 4th Military Medical Univ
Xi’an, Shanxi, China, 710032
4
The 1st Affiliated Hospital - Medical School of Zhejiang Univ.
Hangzhou, Zhejiang, China, 310003