Clinical trial NCT00272467: Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy
Official title: A Comparative Study on the Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stomach Ulcer
Keywords: Helicobacter pylori
Stomach ulcer
Rebamipide
Omeprazole
Lead sponsor: Korea Otsuka International Asia Arab
Sponsor class: INDUSTRY
Collaborators: name: Zhejiang Otsuka Pharmaceutical Co., Ltd.
name: Korea Otsuka Pharmaceutical Co., Ltd.
First posted: 2006-01-06
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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 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

Primary outcomes:
measure: Gastric ulcer healing rate
timeFrame: at 12 weeks after the initial administration of the study medication
Secondary outcomes:
measure: Gastric ulcer healing rate in cases with successful H.pylori eradication and H.pylori eradication failure (12 weeks after administration of the study medication.)
timeFrame: at 12 weeks after the initial administration of the study medication
measure: Serum gastrin level
timeFrame: at 8 and 12 weeks after the initial administration of study medication
measure: Economical efficiency
timeFrame: drug cost/effect ratio
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The 1st Affiliated hospital - Zhongshan Univ.
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital - Nanfang Medical Univ.
state: Guangdong
city: Xi'An
country: China
facility: Xijing Hospital - The 4th Military Medical Univ
state: Shanxi
city: Hangzhou
country: China
facility: The 1st Affiliated Hospital - Medical School of Zhejiang Univ.
state: Zhejiang
city: Shanghai
country: China
facility: Ren-Ji Hospital - Shanghai Second Medical Univ.
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Seoul National University
Study officials:
affiliation: Asan Medical Center, Ulsan University
name: Jin-Ho Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: