The Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers: A Randomized, Parallel-controlled Multi-center Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 7
- 主要终点
- The eradication rate of H. pylori infection
研究概览
简要总结
Helicobacter pylori (Hp) infection is one of the important causes of gastrointestinal diseases, including gastritis, peptic ulcer, and malignancies, nd the eradication of Hp can effectively cure or prevent these diseases. Now, owing to the increasingly serious antibiotic resistance, Hp eradication rate is, however, becoming decreased. In order to improve the eradication rate of Hp, clinicians pay great attention to choose more effective treatment.
Ilaprazole Enteric-Coated Tablets is a new generation of proton pump inhibitor (PPI). Previous research found that Ilaprazole had a more prolonged half-life and higher suppression of gastric acid secretion. In addition, its metabolism is not significantly influenced by CYP2C19, compared to the available PPIs. Doxycycline is in the tetracycline antibiotic class, has a stronger antibacterial force than tetracycline and its antibacterial spectrum is basically the same as tetracycline and doxycycline, so far, it is not widely used. Preliminary observations showed that Ilaprazole/Doxycycline-based quadruple therapy was effective in treating Hp infection, with less adverse reactions and good compliance with patients.
In this study, a multi-center, randomized, parallel controlled trial will be conducted in 7 hospitals in Hunan Province, China, to observe the clinical efficacy and safety of the Bismuth-containing quadruple therapy with Ilaprazole, Doxycycline, Furazolidone and Bismuth Potassium Citrate in the treatment of Hp infected duodenal ulcer. It is expected to complete 200 effective cases, including 100 cases in the experimental group and 100 cases in the control group.
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
- 否
入选标准
- •Has endoscopic evidence of active duodenal ulcer(within a week before participate), accompanying or not accompanied with abdominal pain/abdominal discomfort, acid, heartburn, abdominal distention, belching and other corresponding symptoms.
- •The diameter of the ulcer is 0.3 to 2.0cm, and the number is less than or equal
- •Has evidence(s) of Hp infection. (13C-UBT/14C-UBT/Pathological test)
- •Has a history of antiacid medication, but has been stopped for more than 2 weeks.
- •Has not used antibiotics and (or) bismuth agents in nearly four weeks.
- •Understand and be willing to participate in this clinical trial.
排除标准
- •Has been taking ulcer medications, such as non-steroidal anti-inflammatory drugs, adrenal corticosteroids etc.
- •Has allergic and idiosyncratic responses to the tested drugs and (or) control drugs.
- •Has a diagnosis of duodenal carcinelcosis or a duodenal ulcer can not rule out the the possibility of malignancy (patients with gastrointestinal mucosal epithelial mild atypical hyperplasia are not ruled out) or compound ulcers.
- •Has severe or progressive dysphagia, weight loss, gastrointestinal bleeding or other alarm symptoms.
- •Has esophageal or gastric varices, Zollinger-Ellison syndrome, or serious complications such as pyloric obstruction, active bleeding in the endoscope; esophageal erosion or ulcers, other digestive serious diseases, Such as Crohn's disease, ulcerative colitis.
- •Has a history of gastric acid suppression surgery, esophageal surgery, or digestive organ surgery, with the exception of simple suture of perforation.
- •Is pregnant, breastfeeding or has a family planning during whole trail.
- •Has serious cardiovascular, pulmonary, hepatic, renal, hematological or endocrine disease with uncontrolled condition.
- •Has participated in other clinical trials within 3 months prior to the trial.
- •Is required to use the prescribed anti-ulcer drug during the trial.
- •Has a history of drug and (or) alcohol abuse.
- •Has restriction on sodium, with metabolic alkalosis and (or) hypocalcemia.
- •Has a long-term use of clopidogrel.
- •Has other reasons for not to participating in clinical trials.
研究组 & 干预措施
group 1
week1 to week2：Doxycycline Hyclate Enteric-Coated Capsules 0.1g,orally,twice daily,taken with meals, Ilaprazole Enteric-Coated Tablets 5mg,orally,twice daily, Furazolidone Tablets 0.1g,orally,twice daily,taken with meals, Bismuth Potassium Citrate Tablets 220mg,orally,twice daily week3 to week4：Ilaprazole Enteric-Coated Tablets 5mg,orally,once daily
干预措施: Doxycycline Hyclate Enteric-Coated Capsules (Drug)
group 1
week1 to week2：Doxycycline Hyclate Enteric-Coated Capsules 0.1g,orally,twice daily,taken with meals, Ilaprazole Enteric-Coated Tablets 5mg,orally,twice daily, Furazolidone Tablets 0.1g,orally,twice daily,taken with meals, Bismuth Potassium Citrate Tablets 220mg,orally,twice daily week3 to week4：Ilaprazole Enteric-Coated Tablets 5mg,orally,once daily
干预措施: Ilaprazole Enteric-Coated Tablets (Drug)
group 1
week1 to week2：Doxycycline Hyclate Enteric-Coated Capsules 0.1g,orally,twice daily,taken with meals, Ilaprazole Enteric-Coated Tablets 5mg,orally,twice daily, Furazolidone Tablets 0.1g,orally,twice daily,taken with meals, Bismuth Potassium Citrate Tablets 220mg,orally,twice daily week3 to week4：Ilaprazole Enteric-Coated Tablets 5mg,orally,once daily
干预措施: Furazolidone Tablets (Drug)
group 1
week1 to week2：Doxycycline Hyclate Enteric-Coated Capsules 0.1g,orally,twice daily,taken with meals, Ilaprazole Enteric-Coated Tablets 5mg,orally,twice daily, Furazolidone Tablets 0.1g,orally,twice daily,taken with meals, Bismuth Potassium Citrate Tablets 220mg,orally,twice daily week3 to week4：Ilaprazole Enteric-Coated Tablets 5mg,orally,once daily
干预措施: Potassium Citrate Tablets (Drug)
group 2
Amoxicillin Capsules 1g,orally,twice daily,taken with meals, Ilaprazole Enteric-Coated Tablets 5mg,orally,twice daily, Furazolidone Tablets 0.1g,orally,twice daily,taken with meals, Bismuth Potassium Citrate Tablets 220mg,orally,twice daily.
week3 to week4：Ilaprazole Enteric-Coated Tablets 5mg,orally,once daily
干预措施: Amoxicillin Capsules (Drug)
group 2
Amoxicillin Capsules 1g,orally,twice daily,taken with meals, Ilaprazole Enteric-Coated Tablets 5mg,orally,twice daily, Furazolidone Tablets 0.1g,orally,twice daily,taken with meals, Bismuth Potassium Citrate Tablets 220mg,orally,twice daily.
week3 to week4：Ilaprazole Enteric-Coated Tablets 5mg,orally,once daily
干预措施: Ilaprazole Enteric-Coated Tablets (Drug)
group 2
Amoxicillin Capsules 1g,orally,twice daily,taken with meals, Ilaprazole Enteric-Coated Tablets 5mg,orally,twice daily, Furazolidone Tablets 0.1g,orally,twice daily,taken with meals, Bismuth Potassium Citrate Tablets 220mg,orally,twice daily.
week3 to week4：Ilaprazole Enteric-Coated Tablets 5mg,orally,once daily
干预措施: Furazolidone Tablets (Drug)
group 2
Amoxicillin Capsules 1g,orally,twice daily,taken with meals, Ilaprazole Enteric-Coated Tablets 5mg,orally,twice daily, Furazolidone Tablets 0.1g,orally,twice daily,taken with meals, Bismuth Potassium Citrate Tablets 220mg,orally,twice daily.
week3 to week4：Ilaprazole Enteric-Coated Tablets 5mg,orally,once daily
干预措施: Potassium Citrate Tablets (Drug)
结局指标
主要结局
The eradication rate of H. pylori infection
时间窗: Visit period 3 (After day 56)
Evaluated by 13C-urea breath test (13C-UBT), 14C-urea breath test (14C-UBT), or Pathological examination.
次要结局
- The healing rate of duodenal ulcer(s)(Visit period 2 (day 28±1))
- Number of duodenal ulcer(s)(Visit period 2 (day 28±1))
- Maximum diameter of duodenal ulcer(s)(Visit period 2 (day 28±1))
- Surrounding inflammation and(or) erosion of duodenal ulcer(s)(Visit period 2 (day 28±1))
- Incidence of bleeding(Visit period 2 (day 28±1))
- Improvement of gastric symptoms(Screening period (day -3~0), Visit period 1 (day 14±1), Visit period 2 (day 28±1))
研究者
XU CANXIA
Director, Clinical Professor of Department of Gastroenterology, Principal Investigator
The Third Xiangya Hospital of Central South University