A Registry-Based Observational Study Assessing Clinical Outcomes In Familial Adenomatous Polyposis In Patients Receiving Celecoxib (Celebrex(Registered), Onsenal(Registered)) Compared With Control Patients
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.
Observational
Observational Model: Cohort
Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA
Time(months): [date of first excisional polypectomy of rectal polyp post IRA minus date of prior IRA plus 1] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient's most recent FAP-related surgery date=index date for Matched Control.
Up to 8 years prior to baseline
No
Pfizer CT.gov Call Center
Study Director
Pfizer
United States: Food and Drug Administration
NQ4-00-02-012
NCT00151476
November 2004
November 2008
Name | Location |
---|---|
Pfizer Investigational Site | Cincinnait, Ohio 45236 |