Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given X 10 Days With Omeprazole in Eradication of Helicobacter Pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given X 7 Days
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Helicobacter Pylori Eradication Confirmed by Urea Breath Test
研究概览
简要总结
This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) in H. Pylori eradication. It is hypothesized that quadruple therapy will be comparable in efficacy to triple therapy. Subjects with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 6 and 10 follow-up visits, a urea breath test (UBT) will be performed to confirm eradication.
详细描述
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 30 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects assigned to OAC will be treated for 7 days. Those assigned to Pylera will be treated for 10 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 8 and 14.
Follow-up: includes two visits. approximately one and two months post-treatment. Eradication of H. Pylori will be confirmed through UBT, and resistance will be evaluated in case of treatment failure. These subjects will undergo an endoscopy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive H. Pylori status;
- •Presence of upper gastro-intestinal symptoms;
- •Mental and legal ability to sign informed consent.
排除标准
- •Previous surgery of the GI tract;
- •Clinically significant impairment of renal or hepatic function;
- •Severe unstable cardiovascular, pulmonary or endocrine disease;
- •Barrett's oesophagus or high-grade dysplasia;
- •Dysphagia or vomiting as major symptoms.
研究组 & 干预措施
OAC 7 days
Triple therapy, given for 7 days at a dose of omeprazole 20 mg twice daily, amoxicillin 500 mg 2 capsules twice daily, and clarithromycin 500 mg 1 tablet twice daily
干预措施: Omeprazole, amoxicillin, clarithromycin (Drug)
OBMT 10 days
OBMT (Pylera), consisting of a 3 in 1 capsule, made of bismuth subcitrate potassium 120 mg, metronidazole 125 mg, and tetracycline 125 mg, administered as 3 capsules 4 times daily. Omeprazole 20 mg is administered twice daily.
干预措施: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole (Drug)
结局指标
主要结局
Helicobacter Pylori Eradication Confirmed by Urea Breath Test
时间窗: Week 6 and week 10 follow-up visits
H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits.
次要结局
- Number of Patients Experiencing Treatment Emergent Adverse Events.(at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits.)
- H. Pylori Eradication and Presence or Past History of Peptic Ulcers(Week 6 and week 10 follow-up visits)
- Clarithromycin Resistance(Measured at baseline)
- Metronidazole Resistance(Measured at baseline)
- Overall Compliance to Study Medications(At the end of the treatment phase (days 8-14))
- Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level(Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only)