临床试验/NCT01667718

NCT01667718已完成4 期

Levofloxacin-containing Therapy for Helicobacter Pylori Treatment

Shanghai Jiao Tong University School of Medicine1 个研究点分布在 1 个国家目标入组 161 人开始时间: 2012年5月最近更新: 2012年12月13日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 161
试验地点: 1
主要终点: eradication rate of Helicobacter pylori

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and without Bismuth for H.pylori treatment.

详细描述

The success rate of the standard triple therapy for H. pylori infection is decreasing recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

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: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcer

排除标准

•patients with peptic ulcer, previous H.pylori eradication therapy, previous gastric surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory therapy, antibiotics or bismuth in the preceding 4 weeks, or allergy to any one of the medications

研究组 & 干预措施

Levofloxacin-triple therapy

Active Comparator

Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin

干预措施: Lansoprazole (Drug)

Levofloxacin-triple therapy

Active Comparator

Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin

干预措施: Levoﬂoxacin (Drug)

Levofloxacin-triple therapy

Active Comparator

Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin

干预措施: Amoxicillin (Drug)

Levofloxacin-quadruple therapy

Experimental

Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin

干预措施: Bismuth (Drug)

Levofloxacin-quadruple therapy

Experimental

Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin

干预措施: Lansoprazole (Drug)

Levofloxacin-quadruple therapy

Experimental

Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin

干预措施: Levoﬂoxacin (Drug)

Levofloxacin-quadruple therapy

Experimental

Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin

干预措施: Amoxicillin (Drug)

结局指标

主要结局

eradication rate of Helicobacter pylori

时间窗: 2 months

次要结局

未报告次要终点

研究者

发起方

Shanghai Jiao Tong University School of Medicine

申办方类型

Other

责任方

Principal Investigator

主要研究者

Dr. HONG LU

Professor of GI Division

Shanghai Jiao Tong University School of Medicine

研究点 (1)

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