drugset / Trial / NCT00808743
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2009-05
- Primary completion
- 2011-07
- Completion
- 2013-01
Publications
- van Heumen BW, Roelofs HM, te Morsche RH, Nagengast FM, Peters WH. Duodenal mucosal risk markers in patients with familial adenomatous polyposis: effects of celecoxib/ursodeoxycholic acid co-treatment and comparison with patient controls. Orphanet J Rare Dis. 2013 Nov 19;8:181. doi: 10.1186/1750-1172-8-181.
- van Heumen BW, Roelofs HM, Vink-Borger ME, Dekker E, Mathus-Vliegen EM, Dees J, Koornstra JJ, Langers AM, Nagtegaal ID, Kampman E, Peters WH, Nagengast FM. Ursodeoxycholic acid counteracts celecoxib in reduction of duodenal polyps in patients with familial adenomatous polyposis: a multicentre, randomized controlled trial. Orphanet J Rare Dis. 2013 Aug 6;8:118. doi: 10.1186/1750-1172-8-118.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Celecoxib | Other / unclassified | 400 mg | Oral |
| Subject | Ursodeoxycholic Acid | Small molecule | 1000 mg | Oral |
| Subject | Ursodeoxycholic Acid | Small molecule | 1500 mg | Oral |
| Subject | Ursodeoxycholic Acid | Small molecule | 2000 mg | Oral |