Clinical trial · Interventional
Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)
A Phase III Placebo-Controlled Trial Of Celecoxib In Genotype Positive Subjects With Familial Adenomatous Polyposis
NCT00585312CI-TRIAL-00050211CHIPterminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): See termination reason in detailed description.
Summary
Brief summary (as posted)
To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Polyposis Coli | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Celecoxib
- description
- celecoxib, 16 mg/kg/day, for 5 years
- interventionNames
- Drug: Celecoxib
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Masked, placebo comparator
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Time to Disease Progression
- timeFrame
- 5 years
- description
- Time to disease progression was defined as the time from randomization to the earliest occurrence of one or more of the following events: 1. Appearance of ≥20 polyps (\>2 mm in size) at any colonoscopy during the study (Polyps); or 2. Diagnosis of colorectal malignancy (ColMal).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Age 10-17 years * Confirmed deleterious FAP genotype based on central genetic testing or personal history ot \>2 colorectal adenomas and a parent with the diagnosis of FAP and either A, B or C below A: Non-attenuated FAP genotype B: Attenuated FAP genotype and a personal history of colorectal adenomas and a first degree relative with FAP C: No genotype identified with a personal history of \> 2 adenomas and have a parent with FAP * Less than 30 polyps, which need to be removed to render the colon polyp-free before study drug can be given Exclusion Criteria: * Diagnosis of attenuated FAP based on central genetic testing in the absence of a personal history of \>2 colorectal adenomas and a first degree relative (parent or sibling) with FAP. * Sensitivity to COX-2 inhibitors
References
Publications (0)
Data not yet available
No reference posted for this study.