NCT04784910已完成3 期
A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 423 人开始时间: 2021年5月21日最近更新:
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
- 423
- 试验地点
- 1
- 主要终点
- Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator
研究概览
简要总结
The study aims to demonstrate the preventive effect of DWP14012 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of DWP14012 20 mg.
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
- •Male and female adults aged ≥ 19 years at the time of informed consent
- •Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks
- •Subjects with at least one of the following risk factors for ulcer development at screening.
- •Subjects who have no gastric or duodenal mucosal break or have ulcer in the scarring stage based on the EGD result at screening.
排除标准
- •Subjects with esophagitis, gastroesophageal varix, esophagus, Barrett's esophagus, acute gastrointestinal bleeding and else based on the screening EGD results.
- •Subjects who have undergone gastroduodenal surgery or total small bowel resection
- •Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
- •Subjects who have had a malignant tumor in the last 5 years
- •Subjects who history of hypersensitivity to the IP ingredients, aspirin and NSAIDs
研究组 & 干预措施
DWP14012 20mg
Experimental
orally, once daily
干预措施: Lansoprazole 15 mg placebo (Drug)
DWP14012 20mg
Experimental
orally, once daily
干预措施: DWP14012 20mg (Drug)
Lansoprazole 15mg
Active Comparator
orally, once daily
干预措施: Lansoprazole 15 mg (Drug)
Lansoprazole 15mg
Active Comparator
orally, once daily
干预措施: DWP14012 20mg placebo (Drug)
结局指标
主要结局
Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator
时间窗: at 24 weeks
次要结局
- Proportion of subjects who develop peptic ulcer by Week 12 as assessed by investigator(at 12 weeks)
- Proportion of subjects with endoscopic gastric or duodenal bleeding** by Week 12 and Week 24(at 12, 24 weeks)
研究者
研究点 (1)
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