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

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Celecoxib

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.