Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis (PreDuoFAP)
This study has been completed.
Sponsor:
Radboud University
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00808743
First received: December 15, 2008
Last updated: May 15, 2013
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Familial Adenomatous Polyposis Duodenal Neoplasms Duodenal Polyps |
Drug: Celecoxib Drug: Ursodeoxycholic acid Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Prevention of Progression of Duodenal Adenomas to Cancer in Patients With Familial Adenomatous Polyposis (FAP) |
Resource links provided by NLM:
Further study details as provided by Radboud University:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Cell proliferation, in normal mucosa and adenomas (if present) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
- Biliary acid profile (if present) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 37 |
| Study Start Date: | May 2009 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808743
Locations
| Netherlands | |
| 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 | |
Sponsors and Collaborators
Radboud University
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 |
More Information
No publications provided
| Responsible Party: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00808743 History of Changes |
| Other Study ID Numbers: | RUN 2008-4198, ABR nr.: NL23569.091.08, CMO: 2008/148, EudraCT: 2008-003696-43 |
| Study First Received: | December 15, 2008 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
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 |
Additional relevant MeSH terms:
|
Adenoma Neoplasms Duodenal Neoplasms Adenomatous Polyposis Coli Polyps Colorectal Neoplasms Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases |
Duodenal Diseases Intestinal Diseases Adenomatous Polyps Colonic Neoplasms Neoplastic Syndromes, Hereditary Colonic Diseases Intestinal Polyposis Genetic Diseases, Inborn Pathological Conditions, Anatomical Rectal Diseases Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Nasopharyngeal Diseases Pharyngeal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013