NCT07533266尚未招募4 期
A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Fexuclue Tab. 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 360 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
- 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 Fexuprazan 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 Fexuprazan 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
Fexuprazan 20mg
Experimental
Fexuprazan 20mg orally, once daily
干预措施: Fexuprazan 20mg (Drug)
Fexuprazan 20mg
Experimental
Fexuprazan 20mg orally, once daily
干预措施: Lansoprazole 15 mg placebo (Drug)
Lansoprazole 15mg
Active Comparator
Lansoprazole 15mg orally, once daily
干预措施: Fexuprazan 20mg placebo (Drug)
Lansoprazole 15mg
Active Comparator
Lansoprazole 15mg orally, once daily
干预措施: Lansoprazole 15 mg (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: From enrollment to the end of treatment at 24 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
Unknown
RCT of Nivarana FastAid oil® in chronic and nonhealing ulcersCTRI/2025/09/094146OzoNiv Pvt Ltd60
招募中
2 期
Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled TrialNCT07267260King Edward Medical University154
已完成
3 期
Study Comparing Fexuprazan and Esomeprazole in Patients With Gastroesophageal Reflux DiseaseNCT07326904Indonesia University145
尚未招募
4 期
Soreze Advance Gel for treatment of Pressure Ulcer Healing and Wound Care in Adult SubjectsCTRI/2024/12/078059Amaterasu Life sciences LLP12
尚未招募
不适用
Treatment of non healing Wound using Dushta-Vrana Prashaman Lepa and Haridra AvachurnanaCTRI/2024/10/075665Uttarakhand Ayurved University32