Status:
UNKNOWN
Ursodeoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis (FAP) Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Axcan Pharma
Conditions:
Adenomatous Polyposis Coli, Familial
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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 (UDC...
Detailed Description
We designed a randomized double blinded study to evaluate the efficiency of UDCA in the treatment of duodenal adenomas. One hundred patients are planned to be included. Fifty will receive UDCA and fif...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00134758
Start Date
October 1 2004
End Date
October 1 2009
Last Update
July 29 2009
Active Locations (1)
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1
Saint-Antoine Hospital
Paris, France, 75012