Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP) - Tabular View

Tracking Information

First Received Date ^ICMJE

January 1, 2008

Last Updated Date

November 5, 2009

Start Date ^ICMJE

September 2006

Estimated Primary Completion Date

May 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00585312 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare colorectal polyp burden over 5 years for subjects treated with celecoxib versus subjects treated with placebo. [ Time Frame: 5 years ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
To compare colorectal polyp burden over 5 years for subjects treated with celecoxib versus subjects treated with placebo. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Adenomatous Polyposis Coli

Intervention ^ICMJE

Drug: Celecoxib
Drug: Placebo

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

May 2017

Estimated Primary Completion Date

May 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

10 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^ICMJE

United States, Belgium, Czech Republic, Italy, South Africa, Spain, Sweden

Administrative Information

NCT ID ^ICMJE

NCT00585312

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer Inc

Study ID Numbers ^ICMJE

A3191193

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP