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Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

Last updated on December 5, 2018

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Study Location
Pfizer Investigational Site
Chicago, Illinois, 60612 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Adenomatous Polyposis Coli
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00585312
Pfizer
Terminated
Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

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Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
106
October 2013
October 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
10 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Hong Kong,   Hungary,   Israel,   Italy,   Puerto Rico,   Slovakia,   South Africa,   Spain,   Sweden,   Ukraine,   United Kingdom,   United States
Chile
 
NCT00585312
A3191193
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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