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| ID | Type | Description | Link |
|---|---|---|---|
| ABR nr.: NL23569.091.08 | |||
| CMO: 2008/148 | |||
| EudraCT: 2008-003696-43 |
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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Patients receive oral celecoxib twice daily and oral placebo twice daily |
|
| Group 2 | Experimental | Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | Celecoxib: 400mg twice daily, orally, 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures) | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cell proliferation, in normal mucosa and adenomas (if present) | Baseline, 6 months | |
| Biliary acid profile (if present) | Baseline, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Incapability of signing informed consent
Active gastric or duodenal ulcer, gastrointestinal bleeding
Cardiovascular disease or risk:
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
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Amsterdam | Netherlands | ||||
| University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24245549 | Derived | 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. | |
| 23919274 | Derived |
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| Ursodeoxycholic acid |
| Drug |
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 | Drug | 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 |
|
| Groningen |
| Netherlands |
| Leiden University Medical Center | Leiden | Netherlands |
| University Medical Center St. Radboud | Nijmegen | Netherlands |
| Erasmus Medical Center | Rotterdam | Netherlands |
| 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. |
| ID | Term |
|---|---|
| D011125 | Adenomatous Polyposis Coli |
| D004379 | Duodenal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D011127 | Polyps |
| D000236 | Adenoma |
| D018256 | Adenomatous Polyps |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D009371 | Neoplasms by Site |
| D003108 | Colonic Diseases |
| D044483 | Intestinal Polyposis |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004378 | Duodenal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
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