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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00808743
Other study ID # RUN 2008-4198
Secondary ID ABR nr.: NL23569
Status Completed
Phase Phase 2/Phase 3
First received December 15, 2008
Last updated May 15, 2013
Start date May 2009
Est. completion date January 2013

Study information

Verified date August 2010
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date January 2013
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Intervention

Drug:
Celecoxib
Celecoxib: 400mg twice daily, orally, 6 months
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
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

Locations

Country Name City State
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

Sponsors (2)

Lead Sponsor Collaborator
Radboud University Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures) Baseline, 6 months No
Secondary Cell proliferation, in normal mucosa and adenomas (if present) Baseline, 6 months No
Secondary Biliary acid profile (if present) Baseline, 6 months No
See also
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Completed NCT02961374 - Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer Phase 2
Completed NCT01483144 - Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP) Phase 3
Completed NCT00641147 - Curcumin in Treating Patients With Familial Adenomatous Polyposis Phase 2
Recruiting NCT03471403 - Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis
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Active, not recruiting NCT03847636 - CryoBalloon Ablation for Treatment of Duodenal Adenomas N/A
Not yet recruiting NCT05112822 - Testing Obeticholic Acid (OCA) for Familial Adenomatous Polyposis (FAP) Phase 1
Recruiting NCT02656134 - Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis (FAP) N/A
Withdrawn NCT01245816 - A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP) Phase 3
Recruiting NCT04709445 - Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses N/A
Enrolling by invitation NCT05402891 - The CHAMP-study: The CHemopreventive Effect of Lithium in Familial AdenoMatous Polyposis Phase 2