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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00808743
First Posted: December 16, 2008
Last Update Posted: May 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Radboud University
December 15, 2008
December 16, 2008
May 16, 2013
May 2009
July 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00808743 on ClinicalTrials.gov Archive Site
  • Cell proliferation, in normal mucosa and adenomas (if present) [ Time Frame: Baseline, 6 months ]
  • Biliary acid profile (if present) [ Time Frame: Baseline, 6 months ]
  • Cell proliferation, in normal mucosa and adenomas (if present) [ Time Frame: Baseline, 6 months ]
  • Biliary acid profile [ Time Frame: Baseline, 6 months ]
Not Provided
Not Provided
 
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
  • Familial Adenomatous Polyposis
  • Duodenal Neoplasms
  • Duodenal Polyps
  • 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

  • Active Comparator: Group 1
    Patients receive oral celecoxib twice daily and oral placebo twice daily
    Interventions:
    • Drug: Celecoxib
    • Drug: Placebo
  • Experimental: Group 2
    Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily
    Interventions:
    • Drug: Celecoxib
    • Drug: Ursodeoxycholic acid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
January 2013
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00808743
RUN 2008-4198
ABR nr.: NL23569.091.08
CMO: 2008/148
EudraCT: 2008-003696-43
No
Not Provided
Not Provided
Radboud University
Radboud University
Dutch Cancer Society
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
Radboud University
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP