Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis (PreDuoFAP)

May 15, 2013 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center
      • Groningen, Netherlands
        • University Medical Center
      • Leiden, Netherlands
        • Leiden University Medical Center
      • Nijmegen, Netherlands
        • University Medical Center St. Radboud
      • Rotterdam, Netherlands
        • Erasmus Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Patients receive oral celecoxib twice daily and oral placebo twice daily
Drug: Celecoxib
Celecoxib: 400mg twice daily, orally, 6 months
Drug: 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
Experimental: Group 2
Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily
Drug: Celecoxib
Celecoxib: 400mg twice daily, orally, 6 months
Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Cell proliferation, in normal mucosa and adenomas (if present)
Time Frame: Baseline, 6 months
Baseline, 6 months
Biliary acid profile (if present)
Time Frame: Baseline, 6 months
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Dutch Cancer Society

Investigators

  • Principal Investigator: Fokko M Nagengast, MD, Ph D, University Medical Center St. Radboud Nijmegen, The Netherlands
  • Principal Investigator: Bjorn WH van Heumen, MD, University Medical Center St. Radboud Nijmegen, The Netherlands
  • Principal Investigator: Wilbert HM Peters, Ph D, University Medical Center St Radboud Nijmegen, The Netherlands
  • Principal Investigator: Ellen Kampman, Ph D, University Medical Center St Radboud Nijmegen, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

December 15, 2008

First Submitted That Met QC Criteria

December 15, 2008

First Posted (Estimate)

December 16, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2013

Last Update Submitted That Met QC Criteria

May 15, 2013

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RUN 2008-4198
  • ABR nr.: NL23569.091.08
  • CMO: 2008/148
  • EudraCT: 2008-003696-43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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