NCT06439563招募中3 期
A Multicenter, Parallel, Double-blind, Randomized, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 Treatment in the Prevention of (NSAIDs)-Induced Peptic Ulcers
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Cumulative proportion of subjects who developed peptic ulcers
研究概览
简要总结
The sutdy aims to to demonstrate the non-inferiority of JP-1366 10 mg compared to Lanston Capsule 15 mg in preventing NSAIDs-induced peptic ulcers and to compare/evaluate the efficacy and safety of JP-1366 10 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
- •Adult male/female aged 19 years or older as of the date of obtaining consent
- •Those who are diagnosed with musculoskeletal diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, or other diseases at the time of screening and require continuous administration of NSAIDs for 24 weeks or more
- •Those with one or more of the following risk factors for ulcer development at the time of screening
- •Subjects who fully understand this study and voluntarily signed the informed consent form.
排除标准
- •Those who cannot undergo upper gastrointestinal endoscopy
- •At the time of screening, those who were confirmed to have active stage ulcers (A1, A2) or healing stage ulcers (H1, H2) in the stomach or duodenum according to the Sakita-Miwa Classification*
- •Those with a confirmed history of malignant tumor within 5 years
- •Those with a confirmed history of signal symptoms suggestive of malignant disease of the gastrointestinal tract
- •Those who need to continuously take corticosteroids, antiplatelet agents, and anticoagulants during this study (however, the following cases are permitted):
- •Pregnant and lactating women or those with a positive pregnancy test result at screening
- •Those who participated in another study and were administered investigational products or had medical devices applied at least once within 4 weeks from the screening visit(Visit 0)
研究组 & 干预措施
JP-1366 10 mg
Experimental
干预措施: Lanston Capsule 15 mg placebo (Drug)
Lanston Capsule 15 mg
Active Comparator
干预措施: Lanston Capsule 15 mg (Drug)
JP-1366 10 mg
Experimental
干预措施: JP-1366 10 mg (Drug)
Lanston Capsule 15 mg
Active Comparator
干预措施: JP-1366 10 mg placebo (Drug)
结局指标
主要结局
Cumulative proportion of subjects who developed peptic ulcers
时间窗: at 24 weeks after administration of investigational products
次要结局
- Proportion of subjects with gastric or duodenal endoscopic bleeding(at 24 weeks after administration of investigational products)
研究者
研究点 (1)
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