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

NCT00134758 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2009-07-29

No results posted yet for this study

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.

Conditions

  • Adenomatous Polyposis Coli, Familial

Interventions

DRUG

Ursodeoxycholic acid

During 2 years : * between 40 and 50 kg : 500 mg/day * between 51 and 75 kg : 750 mg/day * between 76 and 100 kg : 1000 mg/day

DRUG

Placebo

During 2 years : * between 40 and 50 kg : 2 tabs/day * between 51 and 75 kg : 3 tabs/day * between 76 and 100 kg : 4 tabs/day

Sponsors & Collaborators

  • Axcan Pharma

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Yann RA Parc, M.D., Ph.D. · Department of Digestive Surgery, Saint-Antoine Hospital, Hospital of Paris (AP/HP), Pierre et Marie Curie University, 184 rue du Faubourg Saint-Antoine, 75012 Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2009-06-30
Completion
2009-10-31

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00134758 on ClinicalTrials.gov