Official Title: “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).

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2017

Intervention(s) in this Clinical Trial

• Drug: Celecoxib
  • celecoxib, 16 mg/kg/day, for 5 years
• Drug: Placebo
  • Masked, placebo comparator

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Celecoxib
  • celecoxib, 16 mg/kg/day, for 5 years
• Placebo Comparator: Placebo
  • Masked, placebo comparator

Primary Measures

• To compare the time from randomization to treatment failure over a 5 year period in subjects treated with celecoxib vs placebo.
  • Time Frame: 5 years
    Safety Issue?: No

Secondary Measures

• To compare colorectal polyp burden over 5 years for subjects treated with celecoxib versus subjects treated with placebo.
  • Time Frame: 5 years
    Safety Issue?: No
• 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
  • Time Frame: 5 years
    Safety Issue?: No
• 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.
  • Time Frame: 5 years
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00585312

Study ID Number: A3191193

ClinicalTrials.gov Identifier: NCT00585312

Health Authority: United States: Food and Drug Administration

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