Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib
Information source: Pfizer
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adenomatous Polyposis Coli
Intervention: Celecoxib (Drug); Routine Medical Care (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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.
Clinical Details
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
Study design: Cohort, Other
Primary outcome: To evaluate long-term treatment with celecoxib in prolonging the time to FAP-related events
Secondary outcome: Time to first resectional or ablational event for rectal, colonic, pouch, or duodenal adenomasDuodenal adenoma burden Time to conversion from IRA to IPAA Time to FAP-related adverse event
Detailed description:
Both retrospective and prospective data will be utilized. No sampling methods apply.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, BARCELONA 08036, Spain; Completed
Pfizer Investigational Site, Hvidovre, Copenhagen DK-2650, Denmark; Recruiting
Pfizer Investigational Site, Cleveland, Ohio 44195, United States; Recruiting
Pfizer Investigational Site, Toronto, Ontario M5G1X5, Canada; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2004
Ending date: December 2010
Last updated: July 16, 2008
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