drugset / Trial / NCT02721862
Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy
Phase 3
Unknown
100 enrolled
American University of Beirut Medical Center
Makassed General Hospital · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a randomized double-blind placebo-controlled trial with a total of 100 patients who are free of gallstones at baseline. The study involves taking an oral drug (Ursodeoxycholic Acid 250mg) or a placebo twice daily for a period of six months and undergoing a total of three abdominal ultrasounds (at 6 months, at 12 months, and at 18 months) to check for gallstones.
Timeline
- Start
- 2016-03
- Primary completion
- 2018-09
- Completion
- 2019-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ursodeoxycholic Acid | Small molecule | 250 mg | Oral |