A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 416
- 试验地点
- 2
- 主要终点
- Ilaprazole, Lansoprazole peptic ulcer
研究概览
简要总结
To demonstrate the non-inferiority of Ilaprazole 10 mg to the active control in prevention of NSAIDs-associated peptic ulcer, as assessed by the proportion of subjects with peptic ulcer by Week 24
详细描述
Not provided
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females aged 19 years or older on the day of informed consent
- •Subjects requiring continuous treatment or receiving treatment with NSAIDs
- •Subjects with at least one of following peptic ulcer risk factors at the time of Screening
- •Subjects who have provided voluntary informed consent for the study participation after the study is explained
排除标准
- •Subjects with Gastroesophageal varices, Esophageal stricture or ulcerous stenosis, Gastrointestinal bleeding or perforation, Esophageal dysplasia and else based on the screening EGD results.
- •Subjects with inflammatory bowel diseases, pancreatitis, pyloric obstruction, and primary esophageal motility disorder
- •Subjects with confirmed history of malignancy within 5 years prior to Screening
- •Positive human immunodeficiency virus (HIV) antigen/antibody at Screening
研究组 & 干预措施
Lansoprazole 15 mg
Take Lansoprazole 15 mg 1 capsule + Placebo of Ilaprazole 10 mg 1 tablet by mouth, with water, once daily.
干预措施: Ilaprazole Placebo (Drug)
Ilaprazole 10 mg
Take Ilaprazole 10 mg 1 tablet + Placebo of Lansoprazole 15 mg 1 capsule by mouth, with water, once daily.
干预措施: Lansoprazole Placebo (Drug)
Ilaprazole 10 mg
Take Ilaprazole 10 mg 1 tablet + Placebo of Lansoprazole 15 mg 1 capsule by mouth, with water, once daily.
干预措施: Ilaprazole (Drug)
Lansoprazole 15 mg
Take Lansoprazole 15 mg 1 capsule + Placebo of Ilaprazole 10 mg 1 tablet by mouth, with water, once daily.
干预措施: Lansoprazole (Drug)
结局指标
主要结局
Ilaprazole, Lansoprazole peptic ulcer
时间窗: at 24 weeks
Proportion of subjects with newly developed peptic ulcer until Week 24 after the IP treatment
次要结局
- Ilaprazole, Lansoprazole peptic ulcer(at 12 weeks)
- Ilaprazole, Lansoprazole GI bleeding(at 12, 24 weeks)