NL-OMON49056
Completed
Phase 4
rsodeoxycholic acid for the prevention of symptomatic gallstone disease after Roux-en-Y Gastric Bypass and Sleeve Gastrectomy. - UPGRADE
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 985
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Scheduled to undergo Roux\-en\-Y gastric bypass or sleeve gastrectomy for morbid obesity
- •\* An intact gallbladder
Exclusion Criteria
- •\* 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
Outcomes
Primary Outcomes
Not specified
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