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


Phase 4
12 Years
N/A
Not Enrolling
Both
Familial Adenomatous Polyposis (FAP)

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Trial Information

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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort

Outcome Measure:

Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA

Outcome Description:

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.

Outcome Time Frame:

Up to 8 years prior to baseline

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

NQ4-00-02-012

NCT ID:

NCT00151476

Start Date:

November 2004

Completion Date:

November 2008

Related Keywords:

  • Familial Adenomatous Polyposis (FAP)
  • Familial adenomatous polyposis
  • celecoxib
  • IRA
  • IPAA
  • Adenomatous Polyposis Coli

Name

Location

Pfizer Investigational SiteCincinnait, Ohio  45236