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

• Status: Unknown status
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Axcan Pharma
• Treatments: Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• Male or female patients between 18 and 65 years of age

• Weight less than or equal to 100 kg

• Restorative proctocolectomy

• Activated protein C (APC) mutation identified or more than 100 polyps on the colectomy specimen

• SPIGELMAN score of duodenal adenoma greater than or equal to 1

• Efficient contraceptive treatment for pre-menopausal women

• Cooperative patient

• Signed consent

• Social security insurance

Exclusion Criteria:

• SPIGELMAN score of duodenal adenoma equal to 4 with severe dysplasia

• Hepatic disease

• Intermesenteric desmoid tumour

• Any severe disease

• Daily use during the last 3 months of:

• aspirin;

• non-steroid anti-inflammatory drugs;

• tamoxifen;

• cholestyramine.

• Pregnancy

• Breast-feeding