EUCTR2016-003245-29-NL进行中（未招募）1 期
rsodeoxycholic acid for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass and Sleeve Gastrectomy - UPGRADE
Amsterdam AMC, locatie AMC0 个研究点目标入组 980 人开始时间: 2016年12月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 980
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Scheduled to undergo Roux-en-Y gastric bypass or Sleeve Gastrectomy for morbid obesity
- •An intact gallbladder
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 980
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Symptomatic gallstone disease already present before RYGB or Sleeve Gastrectomy
- •Prior bariatric surgery
- •Prior gallbladder surgery
- •Ascertained or presumptive hypersensitivity to active or excipient ingredients of UDCA.
- •Inflammatory bowel disease and other conditions of the small intestine and liver which may interfere with enterohepatic circulation of bile salts (ileal resection and stoma, extra and intra-hepatic cholestasis, severe liver disease)
- •Intake of investigational drug within the last 30 days before the screening
研究者
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