Official Title: “A Registry-Based Observational Study Assessing Clinical Outcomes In Familial Adenomatous Polyposis In Patients Receiving Celecoxib (Celebrex(Registered), Onsenal(Registered)) Compared With Control Patients”

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.

Study Type: Observational

Study Design: Cohort, Other

Both retrospective and prospective data will be utilized. No sampling methods apply.

Intervention(s) in this Clinical Trial

• Drug: Celecoxib
  • 800 mg total daily dosing
• Other: Routine Medical Care
  • Observation

Arms, Groups and Cohorts in this Clinical Trial

• : Celecoxib
  • 800 mg total daily dosing
• : Routine Medical Care - Control Group
  • Observation of subjects treated with routine medical care

Primary Measures

• To evaluate long-term treatment with celecoxib in prolonging the time to FAP-related events
  • Time Frame: 3.75 years
    Safety Issue?: No

Secondary Measures

• Time to first resectional or ablational event for rectal, colonic, pouch, or duodenal adenomas
  • Time Frame: 3.75 years
    Safety Issue?: No
• Duodenal adenoma burden
  • Time Frame: 3.75 years
    Safety Issue?: No
• Time to conversion from IRA to IPAA
  • Time Frame: 3.75 years
    Safety Issue?: No
• Time to FAP-related adverse event
  • Time Frame: 3.75 years
    Safety Issue?: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00151476

Study ID Number: NQ4-00-02-012

ClinicalTrials.gov Identifier: NCT00151476

Health Authority: United States: Institutional Review Board

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