JPRN-jRCTs061180077已完成3 期
Clinical study of ursodeoxycholic acid to evaluate the efficacy and safety of ursodeoxycholic acid for the prevention of common bile duct stones following successful removal.
Keishi Kanno0 个研究点目标入组 21 人开始时间: 2019年3月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
研究概览
简要总结
In this study, we evaluated the efficacy and safety of ursodeoxycholic acid in the prevention of recurrence after treatment of common bile duct stones. In prevention of recurrence, one case of recurrence was observed in both the ursodeoxycholic acid-treated and non-treated groups. No significant changes in secondary endpoints were observed during the 96 week obsevation period, and the only side effect was mild diarrhea, indicating that ursodeoxtcholic acid was safe to use.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Age : 20 years old or older at the time of informed consent
- •2. First treatment of common bile duct stone removal
- •3. Complete removal of CBD stones by endoscopic papillary treatment
- •4. Symptomfree period for more than 3 months after removal treatment and no common bile duct stone was proved by CT scan in the preliminary investigation period
- •5. Written informed consent
排除标准
- •1. A history of gastrectomy
- •2. Current treatment for cancer
- •3. Complete obstruction of the biliary tract
- •4. Current treatment for fulminant hepatitis
- •5. Women who were pregnant or breastfeeding, had signs of pregnancy, or were planning to become pregnant
- •6. Alcohol abuse
- •7. A history of hypersensitivity to the study drug
- •8. Current treatment with another bile acid formulation (Urso or Chino capsule), cholagogue (dehydrocholic acid, Supacal, Felviten, and Inchinkoto) , bile acid adsorbent (cholestimide or Questran), or agents under development
- •9. Patients who were judged to be ineligible for the study by the investigator for other reasons
研究者
相似试验
招募中
4 期
Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia: A Multicenter, Placebo, Randomized Controlled TrialGastric Intestinal MetaplasiaNCT06610760Yongquan Shi196
已完成
3 期
Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of PregnancyPregnancyIntrahepatic CholestasisNCT01576458Turku University Hospital20
Unknown
不适用
Ursodeoxycholic Acid Prevents Total Parenteral Nutrition CholestasisCholestasis of Parenteral NutritionNCT05043194Wei Liu80
已完成
不适用
Clinical study of ursodeoxycholic acid to evaluate the efficacy and safety of ursodeoxycholic acid for the prevention of common bile duct stones following successful removal.Common bile duct stonesJPRN-UMIN000020774Department of General Internal Medicine, Hiroshima University Hospital420
招募中
3 期
The efficacy of ursodeoxycholic acid therapy in delay cholecystectomyAcute cholecystitisIRCT20210309050650N1Zanjan University of Medical Sciences60