跳至主要内容
临床试验/NCT02090738
NCT02090738撤回2 期

A Randomized, Open-label Study on Helicobacter Pylori Eradication With Standard Triple Regimen Plus Acetazolamide

Yonsei University1 个研究点 分布在 1 个国家开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
试验地点
1
主要终点
H. pylori eradication rate

研究概览

简要总结

Helicobacter pylori infection is associated with several gastric diseases, including gastritis, peptic and duodenal ulcers, gastric carcinoma and MALToma. In 1994, the WHO classified the organism as a type 1 carcinogen. In order to eradicate H. pylori, at least two antibiotics and a proton pump inhibitor are used as a standard therapy regimen. Emerging antibiotic resistance to metronidazole or clarithromycin, however, has made successful treatment of infection progressively more difficult, with the success rate of standard triple therapy now at 70%, well below the 80% required for treatment of infectious diseases. Therefore, new treatment regimen is required for successful H. pylori eradication.

On the other hands, many in vitro studies revealed that bacterial carbonic anhydrase in H. pylori has an important role for surviving of H. pylori in the stomach. It was demonstrated that mutation of carbonic anhydrase affected survival of H. pylori. The investigators therefore expected that administration of carbonic anhydrase inhibitor (acetazolamide) with standard H. pylori eradication regimen would increase the eradication rate. Here, the investigators aim to evaluate the efficacy of standard triple regimen plus acetazolamide for H. pylori eradication.

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
19 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age, between 19 and 70
  • H. pylori infected patients

排除标准

  • Previous history of H. pylori eradication
  • Previous history of gastrectomy
  • Administration of PPI, H2 blocker, antibiotics, or bismuth within 1 month prior to enrollment
  • Allergy to sulfonamide
  • Electrolyte imbalance
  • Adrenal insufficiency
  • Pregnancy or breast milk feeding
  • Active infection
  • Severe hepatic dysfunction
  • Severe renal dysfunction
  • Severe bone marrow dysfunction
  • Significant neurologic or psychologic disease

研究组 & 干预措施

Arm1

Experimental

Treatment group

干预措施: Acetazolamide group (Drug)

Arm2

Active Comparator

Control group

干预措施: Standard regimen group (Drug)

结局指标

主要结局

H. pylori eradication rate

时间窗: 1 month from the eradication therapy

H. pylori eradication rate will be assessed by urea breath test after eradication therapy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验