rsodeoxycholic acid for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass and Sleeve Gastrectomy

Phase 1

• Conditions: Prevention of symptomatic gallstone disease; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-003245-29-NL
• Lead Sponsor: Amsterdam AMC, locatie AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-19
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 980

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified