EUCTR2016-003245-29-NL
Active, not recruiting
Phase 1
rsodeoxycholic acid for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass and Sleeve Gastrectomy - UPGRADE
Amsterdam AMC, locatie AMC0 sites980 target enrollmentDecember 19, 2016
ConditionsPrevention of symptomatic gallstone diseaseTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
DrugsUrsodeoxycholic acid
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prevention of symptomatic gallstone disease
- Sponsor
- Amsterdam AMC, locatie AMC
- Enrollment
- 980
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
rsodeoxycholic acid for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass and sleeve gastrectomyGastric bypassbariatric surgerygallstone diseaseNL-OMON20653Amsterdam UMC, location AMC, Amsterdam, Netherlands980
Active, not recruiting
Not Applicable
Secondary prophylaxis after pancreatitisGallstone DissolutionMedDRA version: 15.1Level: LLTClassification code 10050844Term: Pancreatitis due to gallstonesSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]EUCTR2011-003174-89-ESEnrique De Madaria Pascual
Completed
Phase 4
rsodeoxycholic acid for the prevention of symptomatic gallstone disease after Roux-en-Y Gastric Bypass and Sleeve Gastrectomy.NL-OMON49056Academisch Medisch Centrum985
Completed
Phase 3
Study of preventive effect of ursodeoxycholic acid on common bile duct stones.Common bile duct stonesJPRN-jRCTs061180077Keishi Kanno21
Recruiting
Phase 3
The protective effect of Ursodeoxycholic Acid in prevention of hepatic damage in neurological patients treated with Sodium ValporatIRCT20181228042156N1Zabol University of Medical Sciences240