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

NCT00808743 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2013-05-16

No results posted yet for this study

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.

Conditions

Interventions

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

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

Sponsors & Collaborators

  • Dutch Cancer Society

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Fokko M Nagengast, MD, Ph D · University Medical Center St. Radboud Nijmegen, The Netherlands

  • Bjorn WH van Heumen, MD · University Medical Center St. Radboud Nijmegen, The Netherlands

  • Wilbert HM Peters, Ph D · University Medical Center St Radboud Nijmegen, The Netherlands

  • Ellen Kampman, Ph D · University Medical Center St Radboud Nijmegen, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-07-31
Completion
2013-01-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00808743 on ClinicalTrials.gov