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Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis
study id #: NCT00808743
condition: Familial Adenomatous Polyposis, Duodenal Neoplasms, Duodenal Polyps
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.
Drug: Ursodeoxycholic acid
start date: May 2009
estimated completion: January 2013
last updated: May 15, 2013
phase of development: Phase 2, Phase 3
size / enrollment: 37
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
- Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures) [ Time Frame:Baseline ] [ Designated as safety issue: No ]
- Cell proliferation, in normal mucosa and adenomas (if present) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
- Biliary acid profile (if present) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
- Patients with Familial adenomatous Polyposis: APC-mutation identified or more than 100 colorectal polyps on diagnosis
- Spigelman score of duodenal adenoma equal to II or III
- Incapability of signing informed consent
- Active gastric or duodenal ulcer, gastrointestinal bleeding
- Cardiovascular disease or risk:
- Congestive cardiac failure: NYHA class II to IV
- Proven ischemic heart disease and/or cerebrovascular disease
- Risk factors: hypertension, hyperlipidaemia, diabetes mellitus, family history of cardiovascular events (≥2 first degree family members <55 years)
- Renal dysfunction: creatinine clearance below 50mL/min
- Liver dysfunction: albumin below 25 g/L or Child-Pugh-score equal to or below 10
- Known allergic reaction to sulfonamides, NSAIDs or ursodeoxycholic acid
- Use of NSAIDs or ursodeoxycholic acid for more than 1 week during the 6 months prior to the start of the study
- Use of lithium
- Symptomatic gallstones
- Inflammatory bowel disease
- (Possible) pregnancy or breast feeding
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