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Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Cleveland, Ohio, 44195 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Familial Adenomatous Polyposis (FAP)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT00151476
Pfizer
Terminated
Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients

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