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

Primary Purpose

Familial Adenomatous Polyposis, Duodenal Neoplasms, Duodenal Polyps

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Celecoxib
Ursodeoxycholic acid
Placebo
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Familial Adenomatous Polyposis focused on measuring Familial adenomatous polyposis, Adenomatous Polyposis Coli, Digestive System Neoplasms, Gastrointestinal Disease, Intestinal disease, Intestinal neoplasms, Gastrointestinal neoplasms, Polyps, Adenoma, Adenomatous Polyps, Neoplastic Syndromes, Hereditary, Digestive System Diseases, Genetic Diseases, Inborn, Chemoprevention, Celecoxib, Ursodeoxycholic acid, Anti-Inflammatory agents, Non-Steroidal, Cyclooxygenase Inhibitors

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academic Medical Center
  • University Medical Center
  • Leiden University Medical Center
  • University Medical Center St. Radboud
  • Erasmus Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1

Group 2

Arm Description

Patients receive oral celecoxib twice daily and oral placebo twice daily

Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily

Outcomes

Primary Outcome Measures

Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures)

Secondary Outcome Measures

Cell proliferation, in normal mucosa and adenomas (if present)
Biliary acid profile (if present)

Full Information

First Posted
December 15, 2008
Last Updated
May 15, 2013
Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT00808743
Brief Title
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis
Acronym
PreDuoFAP
Official Title
Prevention of Progression of Duodenal Adenomas to Cancer in Patients With Familial Adenomatous Polyposis (FAP)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Adenomatous Polyposis, Duodenal Neoplasms, Duodenal Polyps
Keywords
Familial adenomatous polyposis, Adenomatous Polyposis Coli, Digestive System Neoplasms, Gastrointestinal Disease, Intestinal disease, Intestinal neoplasms, Gastrointestinal neoplasms, Polyps, Adenoma, Adenomatous Polyps, Neoplastic Syndromes, Hereditary, Digestive System Diseases, Genetic Diseases, Inborn, Chemoprevention, Celecoxib, Ursodeoxycholic acid, Anti-Inflammatory agents, Non-Steroidal, Cyclooxygenase Inhibitors

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Patients receive oral celecoxib twice daily and oral placebo twice daily
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
Celecoxib: 400mg twice daily, orally, 6 months
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Cell proliferation, in normal mucosa and adenomas (if present)
Time Frame
Baseline, 6 months
Title
Biliary acid profile (if present)
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fokko M Nagengast, MD, Ph D
Organizational Affiliation
University Medical Center St. Radboud Nijmegen, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bjorn WH van Heumen, MD
Organizational Affiliation
University Medical Center St. Radboud Nijmegen, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wilbert HM Peters, Ph D
Organizational Affiliation
University Medical Center St Radboud Nijmegen, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ellen Kampman, Ph D
Organizational Affiliation
University Medical Center St Radboud Nijmegen, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
University Medical Center
City
Groningen
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands
Facility Name
University Medical Center St. Radboud
City
Nijmegen
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24245549
Citation
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.
Results Reference
derived
PubMed Identifier
23919274
Citation
van 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.
Results Reference
derived

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

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