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.

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

Study Type: Observational

Study Design: Cohort, Other

Study Primary Completion Date: May 2008

The study prematurely discontinued on April 11, 2008 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

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 July 02, 2009

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: Food and Drug Administration

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Link to ClinicalStudyResults.org