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

study id #: NCT00808743

condition: Familial Adenomatous Polyposis, Duodenal Neoplasms, Duodenal Polyps

status: completed

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.

intervention:
Drug: Celecoxib
Drug: Ursodeoxycholic acid
Drug: Placebo

start date: May 2009

estimated completion: January 2013

last updated: May 16, 2013

phase of development: Phase 2, Phase 3

size / enrollment: 37

study design:
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

primary outcomes:

• 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 ]

secondary outcomes:

• 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 ]

inclusion criteria:

exclusion criteria:
- 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

sponsor: Radboud University

investigators:
Principal Investigator: Fokko M Nagengast, MD, PhD
Principal Investigator: Bjorn WH Van Heumen, MD
Principal Investigator: Wilbert HM Peters, PhD
Principal Investigator: Ellen Kampman, PhD

trial center locations: Netherlands