Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 521
- 试验地点
- 12
- 主要终点
- Proportion of patient developing gallstone at 12 month after gastrectomy
研究概览
简要总结
This study evaluates the efficacy and safety of DWJ1319 in the prevention of gallstone formation after gastrectomy in patient with gastric cancer. Two-thirds of the participants will receive DWJ1319, while the other will receive a placebo.
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
- Double (Participant, Investigator)
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 or female at least 19 years of age
- •Patient who undergoes gastrectomy (total, distal or proximal gastrectomy)
- •D1+ or D2 lymph node dissection
- •Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- •Written informed consent
排除标准
- •Patients with cholangitis, cholecystitis, non-functional gall bladder, or biliary obstruction
- •Presence of gallstones on ultrasonography and/or CT
- •History of previous cholecystectomy
- •Patients undergoing pylorus-preserving gastrectomy
- •Pregnant or lactating women and fertile women who is not using proper contraceptive method
- •Patients with history of drug or alcohol abuse within 5 years ago
研究组 & 干预措施
DWJ1319 300 mg BID
DWJ1319 300 mg, orally, twice daily (BID) for up to 12 months
干预措施: DWJ1319 (Drug)
DWJ1319 300 mg QD
DWJ1319 300 mg, orally, once daily (QD), and DWJ1319 placebo-matching capsules, orally, once daily for up to 12 months
干预措施: DWJ1319 (Drug)
DWJ1319 300 mg QD
DWJ1319 300 mg, orally, once daily (QD), and DWJ1319 placebo-matching capsules, orally, once daily for up to 12 months
干预措施: Placebo (Drug)
Placebo
Placebo, orally, twice daily (BID) for up to 12 months
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patient developing gallstone at 12 month after gastrectomy
时间窗: 12 months
次要结局
- Proportion of patient developing gallstone at 3, 6 and 9 month after gastrectomy(3, 6 and 9 months)
- Time to gallstone formation(12 months)