Clinical trial · Interventional
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis
Prevention of Progression of Duodenal Adenomas to Cancer in Patients With Familial Adenomatous Polyposis (FAP)
NCT00808743CI-TRIAL-00010336PreDuoFAPcompletedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Duodenal Neoplasms | Duodenal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Duodenal Polyps | — | UNRESOLVED | — |
| Familial Adenomatous Polyposis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Ursodeoxycholic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1
- description
- Patients receive oral celecoxib twice daily and oral placebo twice daily
- interventionNames
- Drug: Celecoxib
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily
- interventionNames
- Drug: Celecoxib
- Drug: Ursodeoxycholic acid
Primary outcomes (1)
- measure
- Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDvan 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. PMID 24245549
- DERIVEDvan 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. PMID 23919274