NL-OMON49056已完成4 期
rsodeoxycholic acid for the prevention of symptomatic gallstone disease after Roux-en-Y Gastric Bypass and Sleeve Gastrectomy. - UPGRADE
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 985
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Scheduled to undergo Roux-en-Y gastric bypass or sleeve gastrectomy for morbid obesity
- •* An intact gallbladder
排除标准
- •* Symptomatic gallstone disease already present before RYGB
- •* Prior bariatric surgery
- •* Prior gallbladder surgery
- •* Ascertained or presumptive hypersensitivity to active or excipient ingredients of ursodeoxycholic acid.
- •* 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
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