Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis
PreDuoFAP
4 other identifiers
interventional
37
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2009
Typical duration for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2008
CompletedFirst Posted
Study publicly available on registry
December 16, 2008
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedMay 16, 2013
August 1, 2010
2.2 years
December 15, 2008
May 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Cell proliferation, in normal mucosa and adenomas (if present)
Baseline, 6 months
Biliary acid profile (if present)
Baseline, 6 months
Study Arms (2)
Group 1
ACTIVE COMPARATORPatients receive oral celecoxib twice daily and oral placebo twice daily
Group 2
EXPERIMENTALPatients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily
Interventions
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: 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Dutch Cancer Societycollaborator
Study Sites (5)
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, Netherlands
Related Publications (2)
van Heumen BW, Roelofs HM, te Morsche RH, Nagengast FM, Peters WH. Duodenal mucosal risk markers in patients with familial adenomatous polyposis: effects of celecoxib/ursodeoxycholic acid co-treatment and comparison with patient controls. Orphanet J Rare Dis. 2013 Nov 19;8:181. doi: 10.1186/1750-1172-8-181.
PMID: 24245549DERIVEDvan Heumen BW, Roelofs HM, Vink-Borger ME, Dekker E, Mathus-Vliegen EM, Dees J, Koornstra JJ, Langers AM, Nagtegaal ID, Kampman E, Peters WH, Nagengast FM. Ursodeoxycholic acid counteracts celecoxib in reduction of duodenal polyps in patients with familial adenomatous polyposis: a multicentre, randomized controlled trial. Orphanet J Rare Dis. 2013 Aug 6;8:118. doi: 10.1186/1750-1172-8-118.
PMID: 23919274DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2008
First Posted
December 16, 2008
Study Start
May 1, 2009
Primary Completion
July 1, 2011
Study Completion
January 1, 2013
Last Updated
May 16, 2013
Record last verified: 2010-08