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

Phase 2

Completed

• Conditions: Familial Adenomatous Polyposis; Duodenal Neoplasms; Duodenal Polyps
• Interventions: Drug: Celecoxib; Drug: Placebo; Drug: Ursodeoxycholic acid

• Registration Number: NCT00808743
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-15
• Study First Submitted QC: 2008-12-15
• Study First Posted: 2008-12-16
• Study Start: 2009-05
• Status Verified: 2010-08
• Primary Completion: 2011-07
• Study Completion: 2013-01
• Last Update Submitted: 2013-05-15
• Last Update Posted: 2013-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Celecoxib	Patients receive oral celecoxib twice daily and oral placebo twice daily
Group 1	Placebo	Patients receive oral celecoxib twice daily and oral placebo twice daily
Group 2	Celecoxib	Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily
Group 2	Ursodeoxycholic acid	Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily

Primary Outcome Measures

Name	Time	Method
Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures)	Baseline, 6 months

Secondary Outcome Measures

Name	Time	Method
Cell proliferation, in normal mucosa and adenomas (if present)	Baseline, 6 months
Biliary acid profile (if present)	Baseline, 6 months

Trial Locations

Locations (5)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

University Medical Center; 🇳🇱 Groningen, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

University Medical Center St. Radboud; 🇳🇱 Nijmegen, Netherlands