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临床试验/NCT05863858
NCT05863858已完成3 期

High Eradication Rate of Helicobacter Pylori Infection With Moxifloxacin-Based Triple Therapy in Comparison With Levofloxacin-Based Sequential Therapy: Randomized Controlled Trials

Iyad Naeem Muhammad, PhD2 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2020年6月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
162
试验地点
2
主要终点
Helicobacter pylori status one month after treatment.

研究概览

简要总结

The main objective of the study is to compare the effectiveness of moxifloxacin triple therapy with levofloxacin-based sequential therapy in terms of eradication rate, safety, and patient compliance.

详细描述

Patients who were confirmed to be positive for Helicobacter Pylori infection were randomly assigned to the eradication treatments. At four weeks after completion of eradication therapy, H. pylori tests were performed with a Stool antigen test.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Successful isolation of H. pylori from the patient, and
  • patients of at least 18 years of age.

排除标准

  • age under 18 years
  • presence of clinically significant associated conditions (insulin-dependent diabetes mellitus, gastrointestinal bleeding, neoplastic diseases, coagulation disorders, and neurologic, metabolic, hematological or endocrine hepatic, cardiorespiratory, or renal diseases),
  • previous gastric surgery,
  • allergy to any of the drugs used in the study, and (5) pregnancy or breastfeeding.

结局指标

主要结局

Helicobacter pylori status one month after treatment.

时间窗: One month after finishing with therapy.

Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy.

次要结局

  • Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection.(One month after finishing with therapy.)
  • Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection.(One month after finishing with therapy.)

研究者

发起方
Iyad Naeem Muhammad, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Iyad Naeem Muhammad, PhD

Associate Professor

University of Karachi

研究点 (2)

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Eradication of H. Pylori Infection With Moxifloxacin | 临床试验