Pilot Study Assessing the Safety, Tolerability, Compliance and Efficacy of Twice Daily Dosed Pylera Plus Omeprazole as a First Line Treatment of Helicobacter Pylori Infection
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 6
- 主要终点
- H. pylori status confirmed by Urea Breath Test
研究概览
简要总结
The purpose of this study is to evaluate the effect of Pylera when given twice a day. Pylera approved treatment schedule is 3 pills taken 4 times daily, in addition to omeprazole given twice daily. In this trial, subjects with confirmed Helicobacter Pylori infection will receive Pylera treatment and omeprazole twice daily.
详细描述
This study will include three phases: screening, treatment and follow-up.
Screening: this phase will last a maximum of 15 days and subjects eligibility will be evaluated after informed consent signature. Urea breath test (UBT) will be performed in addition to routine baseline evaluations (physical, lab test, etc).
Treatment: subjects will be treated for 10 days. A "confirmation of eligibility" visit will take place on Day 0 and an "end-of-treatment" visit will take place between days 9-14.
Follow-up: approximately one month post-treatment, eradication of H. pylori will be confirmed through UBT
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive H. pylori status through UBT testing
排除标准
- •Documented allergy to any of the drugs contained in the treatment regimen
- •Severe renal insufficiency, renal failure or azotemia
- •Previous surgery of the upper gastrointestinal tract
- •Hepatic failure
- •Pre-existing peripheral neuropathies
- •Use of any experimental drug within 30 days prior to randomization
结局指标
主要结局
H. pylori status confirmed by Urea Breath Test
时间窗: at 6 and 10 weeks following treatment
次要结局
- Tolerability(at the end of treatment, one and two months post-treatment)