drugset / Trial / NCT00134758

Ursodeoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis (FAP) Patients

NCT00134758

RandomizedParallel-groupDouble-blindTreatment

Summary

Malignant transformation of adenomas of the duodenum is now the leading cause of death in familial adenomatous polyposis (FAP) patients who had a restorative proctocolectomy. Ursodeoxycholic acid (UDCA) modifies the biliary acid profile and could reduce the severity of duodenal adenomas and prevent such transformation.

Timeline

Start
2004-10
Primary completion
2009-06
Completion
2009-10

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ursodeoxycholic Acid Small molecule 10 mg/kg Oral
Subject Ursodeoxycholic Acid Small molecule 500 mg Oral
Subject Ursodeoxycholic Acid Small molecule 750 mg Oral
Subject Ursodeoxycholic Acid Small molecule 1000 mg Oral