Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adenomatous Polyposis Coli
Intervention: Celecoxib (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
To test whether celecoxib can be used to prevent colon polyp formation in children with
familial adenomatous polyposis (FAP).
Clinical Details
Official title: A Phase III Placebo-Controlled Trial Of Celecoxib In Genotype Positive Subjects With Familial Adenomatous Polyposis
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: To compare the time from randomization to treatment failure over a 5 year period in subjects treated with celecoxib vs placebo.
Secondary outcome: To compare colorectal polyp burden over 5 years for subjects treated with celecoxib versus subjects treated with placebo.To compare in the intent-to-treat population the time from randomization to treatment failure for subjects treated with celecoxib versus subjects treated with placebo To compare between subjects treated with celecoxib versus subjects treated with placebo the total number of colorectal polyps (>2 mm in size) detected over years 1-5 cumulatively.
Eligibility
Minimum age: 10 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 10-17 years
- Confirmed non-attenuated FAP genotype based on central genetic testing
- Less than 20 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
- Sensitivity to COX-2 inhibitors
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Bruxelles 1200, Belgium; Recruiting
Pfizer Investigational Site, Gent 9000, Belgium; Not yet recruiting
Pfizer Investigational Site, Praha 5 150 06, Czech Republic; Not yet recruiting
Pfizer Investigational Site, Roma 00144, Italy; Recruiting
Pfizer Investigational Site, Roma 00165, Italy; Not yet recruiting
Pfizer Investigational Site, Siena 53100, Italy; Recruiting
Pfizer Investigational Site, Cape Town 7925, South Africa; Recruiting
Pfizer Investigational Site, MADRID 28040, Spain; Recruiting
Pfizer Investigational Site, ZARAGOZA 50009, Spain; Not yet recruiting
Pfizer Investigational Site, Stockholm 171 76, Sweden; Recruiting
Pfizer Investigational Site, Ann Arbor, Michigan 48109, United States; Recruiting
Pfizer Investigational Site, Omaha, Nebraska 68114, United States; Not yet recruiting
Pfizer Investigational Site, Omaha, Nebraska 68198, United States; Not yet recruiting
Pfizer Investigational Site, Cleveland, Ohio 44195, United States; Recruiting
Pfizer Investigational Site, Nashville, Tennessee 37232, United States; Not yet recruiting
Pfizer Investigational Site, Houston, Texas 77030, United States; Recruiting
Pfizer Investigational Site, Salt Lake City, Utah 84112, United States; Recruiting
Pfizer Investigational Site, Salt Lake City, Utah 84113, United States; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: September 2006
Ending date: May 2017
Last updated: October 8, 2009
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