NCT00808743

Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis

Prevention of Progression of Duodenal Adenomas to Cancer in Patients With Familial Adenomatous Polyposis (FAP)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with FAP.

Conditions

• Familial Adenomatous Polyposis
• Duodenal Neoplasms
• Duodenal Polyps

Interventions

Type	Name	Description
DRUG	Celecoxib	Celecoxib: 400mg twice daily, orally, 6 months
DRUG	Ursodeoxycholic acid	Ursodeoxycholic acid: orally, 6 months, dosage based on body weight: below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses
DRUG	Placebo	Placebo: orally, 6 months, dosage based on body weight: below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-07-01
• Completion: 2013-01-01
• First posted: 2008-12-16
• Last updated: 2013-05-16

Locations

5 sites across 1 country: Netherlands