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A Phase III Placebo-Controlled Trial Of Celecoxib In Genotype Positive Subjects With Familial Adenomatous Polyposis


Phase 3
10 Years
17 Years
Open (Enrolling)
Both
Adenomatous Polyposis Coli

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Trial Information

A Phase III Placebo-Controlled Trial Of Celecoxib In Genotype Positive Subjects With Familial Adenomatous Polyposis


Inclusion Criteria:



- Age 10-17 years

- Confirmed deleterious FAP genotype based on central genetic testing or personal
history ot >2 colorectal adenomas and a parent with the diagnosis of FAP and either
A, B or C below A: Non-attenuated FAP genotype B: Attenuated FAP genotype and a
personal history of colorectal adenomas and a first degree relative with FAP C: No
genotype identified with a personal history of > 2 adenomas and have a parent with
FAP

- Less than 30 polyps, which need to be removed to render the colon polyp-free before
study drug can be given

Exclusion Criteria:

- Diagnosis of attenuated FAP based on central genetic testing in the absence of a
personal history of >2 colorectal adenomas and a first degree relative (parent or
sibling) with FAP.

- Sensitivity to COX-2 inhibitors

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

To compare the time from randomization to treatment failure over a 5 year period in subjects treated with celecoxib vs placebo.

Outcome Time Frame:

5 years

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:

A3191193

NCT ID:

NCT00585312

Start Date:

September 2006

Completion Date:

January 2019

Related Keywords:

  • Adenomatous Polyposis Coli
  • FAP
  • Adenomatous Polyposis Coli

Name

Location

Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteSalt Lake City, Utah  84112