Clinical trial · Observational
Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients
A Registry-Based Observational Study Assessing Clinical Outcomes In Familial Adenomatous Polyposis In Patients Receiving Celecoxib (Celebrex(Registered), Onsenal(Registered)) Compared With Control Patients
NCT00151476CI-TRIAL-00080418terminatedResults 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 Detailed Description
Summary
Brief summary (as posted)
This is a registry-based observational study assessing clinical outcomes in FAP patients receiving celecoxib compared with historical/concurrent registry patients who have not received celecoxib. Both retrospective and prospective data will be utilized. No sampling methods apply.
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 |
|---|---|---|---|
| Familial Adenomatous Polyposis (FAP) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
| Routine Medical Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Celecoxib - Routine Medical Care
- description
- 800 mg total daily dosing
- interventionNames
- Drug: Celecoxib
- label
- Control Group - Routine Medical Care
- description
- Observation of subjects treated with routine medical care
- interventionNames
- Other: Routine Medical Care
Primary outcomes (4)
- measure
- Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA
- timeFrame
- Up to 8 years prior to baseline
- description
- Time(months): \[date of first excisional polypectomy of rectal polyp post IRA minus date of prior IRA plus 1\] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient's most recent FAP-related surgery date=index date for Matched Control.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: Celecoxib Treated Patients: * Diagnosis of FAP based on the expression of the FAP phenotype. * Celecoxib treatment prescribed outside of a clinical trial setting with expected duration of celecoxib treatment of at least six months. Historical/Concurrent Control Patients: * Diagnosis of FAP based on the expression of the FAP phenotype. * Be greater than or equal to 12 years old at the time of study enrollment. * Have an endoscopically assessable colonic, rectal, ileal pouch and/or gastroduodenal segment. * For the group of post-surgical patients, IRA or IPAA performed from 1985 onward (in order to assure standardized surgical techniques and post-surgical management). Patients whose primary colorectal surgery was performed prior to 1985 will not be eligible to serve as historical controls. Exclusion Criteria: Celecoxib Treated Patients: * Have received a pharmacological treatment (other than celecoxib) within the last 3 months for their FAP disease including treatment of any extracolonic manifestation of FAP. * Have received a non-steroidal anti-inflammatory drug (NSAID) within the last 3 months, other than celecoxib, for any reason. Historical/Concurrent Control Patients: * Have pharmacological treatment recorded for their FAP disease at the defined index date. * Have received a non-steroidal anti-inflammatory drug (NSAID) within the last 3 months for any reason.
References
Publications (0)
Data not yet available
No reference posted for this study.