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Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients

NCT00151476

TerminatedN/A

Sponsor: Pfizer

Conditions: Familial Adenomatous Polyposis (FAP)

Interventions: Celecoxib, Routine Medical Care

Countries: United States, Canada, Denmark, Spain

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.

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (4)

Cleveland, Ohio, United States
Toronto, Ontario, Canada
Hvidovre, Copenhagen, Denmark
Barcelona, Spain