NCT00272467已完成4 期
A Comparative Study on the Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy
Korea Otsuka International Asia Arab7 个研究点 分布在 2 个国家目标入组 132 人开始时间: 2005年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 7
- 主要终点
- Gastric ulcer healing rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Rebamipide
Experimental
- Dosage (1) The eradication therapy period (for all cases) Amoxicillin 2,000mg/day, clarithromycin 1,000 mg/day and omeprazole 40 mg/day. b.i.d. (morning and evening), oral administration. (2) The ulcer treatment period (on a double-blind basis) Rebamipide 100mg, t.i.d. (before breakfast, evening, before bed).
- Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks
干预措施: Rebamipide (Drug)
Omeprazole
Active Comparator
- Dosage (1) The eradication therapy period (for all cases) Amoxicillin 2,000mg/day, clarithromycin 1,000 mg/day and omeprazole 40 mg/day. b.i.d. (morning and evening), oral administration. (2) The ulcer treatment period (on a double-blind basis) omeprazole 20mg, once daily (before breakfast)
- Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks
干预措施: Omeprazole (Drug)
结局指标
主要结局
Gastric ulcer healing rate
时间窗: at 12 weeks after the initial administration of the study medication
Rebamipide showed 81.5\~87.8% of gastric ulcer healing rate which was not inferior to 82.5\~87.8% healing rate of Omeprazole.
次要结局
- Gastric ulcer healing rate in cases with successful H.pylori eradication and H.pylori eradication failure (12 weeks after administration of the study medication.)(at 12 weeks after the initial administration of the study medication)
- Economical efficiency(drug cost/effect ratio)
- Serum gastrin level(at 8 and 12 weeks after the initial administration of study medication)
研究者
研究点 (7)
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