NCT02084420已完成3 期
PhaseⅢ Study of A Multicenter, Randomized, Double-blind, Active-controlled to Evaluate of Efficacy /Safety as H. Pylori Eradication Effect Between Ilaprazole/Pantoprazole
Il-Yang Pharm. Co., Ltd.18 个研究点 分布在 1 个国家目标入组 323 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 323
- 试验地点
- 18
- 主要终点
- the rate of H.pylori eradication
研究概览
简要总结
The purpose of this study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.
详细描述
This study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 year old ≤ Male or female < 75 year old
- •Patients who had endoscopically confirmed Gastric and/or duodenal ulcer and H.pylori infection confirmed by Urea Breath Test
- •Patients who understand the study conditions
- •Patients who had been given the explanation about the study, and had provided voluntary written informed consent to participate in the stud
排除标准
- •Patients with known allergy or hypersensitivity reaction to the Investigational products
- •Patients who use the Investigational products
- •Patients who undergone H.pylori eradication
- •Patients with abnormal laboratory results, as specified below:
- •Total bilirubin, creatinine > 1.5 x upper limit of normal Aspartate transminase, Alanine transminase, Alkaline phosphatase, Blood urea nitrogen > 2 x upper limit of normal
- •Patients who used Proton Pump Inhibitor agents or antibiotics within the last 2 weeks before the start of the Investigational products
- •Pregnant women and lactating women
- •Women of childbearing potential who were not using a medically acceptable method of contraception during the study period.(Menopausal women who did not have a menstrual period for at least 12 months were considered infertile)
- •Patients with uncontrolled Diabetes mellitus
- •Patients with uncontrolled Hypertension
- •Patients with Alcoholics
- •Patients with a history of malignancy within 5 years prior to the study entry (Day 1) (except for basal cell carcinoma of the skin)
- •Patients who had undergone a esophageal or gastric surgery
- •Patients who had a hereditary disorder as galactose intolerance, lactose intolerance, glucose-galactose malabsorption
- •Patients who had participated in other investigational study within 30 days before the study entry (Day 1)
- •Patients who, in the investigator's opinion, are not suitable for the study for any other reason
研究组 & 干预措施
Ilaprazole or Pantoprazole placebo
Experimental
Ilaprazole 10mg, Pantoprazole 40mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day, PO
干预措施: Ilaprazole (Drug)
Ilaprazole placebo or Pantoprazole
Active Comparator
Pantoprazole 40mg, Ilaprazole 10mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day,PO
干预措施: Pantoprazole (Drug)
结局指标
主要结局
the rate of H.pylori eradication
时间窗: participants will be followed at 7 weeks (visit 4)
次要结局
- the rate of Gastric and/or Duodenal ulcer curation(participants will be followed at 7 weeks (visit 4))
研究者
研究点 (18)
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