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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 Site Detroit, Michigan  48201
Pfizer Investigational Site Cincinnait, Ohio  45236
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Omaha, Nebraska  68198
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Salt Lake City, Utah  84112