Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:10 - 17
Updated:10/2/2013
Start Date:September 2006
End Date:January 2019
Contact:Emergingmed
Email:faptrials@emergingmed.com
Phone:1-877-769-4832

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


To test whether celecoxib can be used to prevent colon polyp formation in children with
familial adenomatous polyposis (FAP).


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
We found this trial at
8
sites
Detroit, Michigan 48202
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Akron, Ohio 44314
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Akron, OH
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Alliance, Nebraska 69301
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Alliance, NE
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Bloomingdale, Illinois 60108
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Bloomingdale, IL
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Bristol, Tennessee 37620
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Bristol, TN
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Houston, Texas 77030
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Houston, TX
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Rochester, New York 14642
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Rochester, NY
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West Jordan, Utah 84088
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West Jordan, UT
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