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

Familial Adenomatous Polyposis Clinical Trial

— PreDuoFAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808743
• Other study ID #: RUN 2008-4198
• Secondary ID: ABR nr.: NL23569
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 15, 2008
• Last updated: May 15, 2013
• Start date: May 2009
• Est. completion date: January 2013

Study information

• Verified date: August 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Duodenal Neoplasms
• Duodenal Polyps
• Familial Adenomatous Polyposis

Intervention

Drug:
• Celecoxib
Celecoxib: 400mg twice daily, orally, 6 months
• 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
• 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

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam
Netherlands	University Medical Center	Groningen
Netherlands	Leiden University Medical Center	Leiden
Netherlands	University Medical Center St. Radboud	Nijmegen
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures)		Baseline, 6 months	No
Secondary	Cell proliferation, in normal mucosa and adenomas (if present)		Baseline, 6 months	No
Secondary	Biliary acid profile (if present)		Baseline, 6 months	No