Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis
NCT ID: NCT00808743
Last Updated: 2013-05-16
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
37 participants
INTERVENTIONAL
2009-05-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group 1
Patients receive oral celecoxib twice daily and oral placebo twice daily
Celecoxib
Celecoxib: 400mg twice daily, orally, 6 months
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
Group 2
Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Spigelman score of duodenal adenoma equal to II or III
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Dutch Cancer Society
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Fokko M Nagengast, MD, Ph D
Role: PRINCIPAL_INVESTIGATOR
University Medical Center St. Radboud Nijmegen, The Netherlands
Bjorn WH van Heumen, MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center St. Radboud Nijmegen, The Netherlands
Wilbert HM Peters, Ph D
Role: PRINCIPAL_INVESTIGATOR
University Medical Center St Radboud Nijmegen, The Netherlands
Ellen Kampman, Ph D
Role: PRINCIPAL_INVESTIGATOR
University Medical Center St Radboud Nijmegen, The Netherlands
Locations
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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
Countries
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References
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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.
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.
Other Identifiers
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ABR nr.: NL23569.091.08
Identifier Type: -
Identifier Source: secondary_id
CMO: 2008/148
Identifier Type: -
Identifier Source: secondary_id
EudraCT: 2008-003696-43
Identifier Type: -
Identifier Source: secondary_id
RUN 2008-4198
Identifier Type: -
Identifier Source: org_study_id
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