Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 2
- 主要终点
- The rate of H.pylori eradication
研究概览
简要总结
Dexlansoprazole MR is the R-enantiomer of lansoprazole that is delivered by a dual delayed release formulation. It is effective for symptom control of patients with gastroesophageal reflux disease. However, its efficacy in the treatment of H.pylori infection remains unclear. This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of H.pylori infection.
详细描述
Helicobacter pylori (H.pylori) infect more than 50% of humans globally. It is the major cause of chronic gastritis, gastric ulcer, duodenal ulcer, gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma (MALToma). H.pylori eradication has become the standard and most widely adopted therapy to cure peptic ulcer disease. This therapy is also strongly recommended in the treatment of H pylori-related MALToma. In regions with high incidence of gastric adenocarcinoma, eradication of H pylori is advocated as a preventative measure. Proton pump inhibitor (PPI) is one of the key medicines in anti-H pylori regimens. It possesses anti-H pylori activity, and, by reducing gastric acid secretion, it also increases bioavailability and activity of some antibiotics. This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of H pylori infection.
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
- Single (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
- •Male or non-pregnant female aged more than 20 years.
- •H. pylori-infected outpatients
- •Mental and legal ability to give a written informed consent.
排除标准
- •previous H pylori-eradication therapy,
- •ingestion of antibiotics or bismuth within the prior 4 weeks,
- •patients with allergic history to the medications used,
- •patients with previous gastric surgery,
- •the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
- •pregnant women.
研究组 & 干预措施
dexlansoprazole based triple therapy
dexlansoprazole MR 60 mg once daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
干预措施: dexlansoprazole based triple therapy (Drug)
rabeprazole-based triple therapy
rabeprazole 20 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
干预措施: rabeprazole-based triple therapy (Drug)
结局指标
主要结局
The rate of H.pylori eradication
时间窗: 6 weeks after finishing study drugs
Evaluate eradication outcome by 13C urea breath test
次要结局
- Drug Compliance(6 weeks after finishing study drugs)
研究者
DENG-CHYANG WU
Clinical Professor
Kaohsiung Medical University