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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00585312

Purpose

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

Condition	Intervention	Phase
Adenomatous Polyposis Coli	Drug: Celecoxib Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Placebo-Controlled Trial Of Celecoxib In Genotype Positive Subjects With Familial Adenomatous Polyposis

Resource links provided by NLM:

Genetics Home Reference related topics: familial adenomatous polyposis Help Me Understand Genetics

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	September 2006
Estimated Study Completion Date:	January 2019
Estimated Primary Completion Date:	January 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Celecoxib: Experimental celecoxib, 16 mg/kg/day, for 5 years	Drug: Celecoxib celecoxib, 16 mg/kg/day, for 5 years
Placebo: Placebo Comparator Masked, placebo comparator	Drug: Placebo Masked, placebo comparator

Eligibility

Ages Eligible for Study:	10 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585312

Contacts

Contact: Pfizer CT.gov Call Center	1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com

Locations

United States, Illinois
Pfizer Investigational Site	Not yet recruiting
Chicago, Illinois, United States, 60612
United States, Michigan
Pfizer Investigational Site	Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Nebraska
Pfizer Investigational Site	Recruiting
Omaha, Nebraska, United States, 68114
Pfizer Investigational Site	Recruiting
Omaha, Nebraska, United States, 68198
United States, Ohio
Pfizer Investigational Site	Recruiting
Cleveland, Ohio, United States, 44195
United States, Texas
Pfizer Investigational Site	Recruiting
Houston, Texas, United States, 77030
United States, Utah
Pfizer Investigational Site	Recruiting
Salt Lake City, Utah, United States, 84112
Pfizer Investigational Site	Recruiting
Salt Lake City, Utah, United States, 84113
Belgium
Pfizer Investigational Site	Recruiting
Bruxelles, Belgium, 1200
Pfizer Investigational Site	Not yet recruiting
Gent, Belgium, 9000
Czech Republic
Pfizer Investigational Site	Recruiting
Praha 5, Czech Republic, 150 06
Italy
Pfizer Investigational Site	Recruiting
Roma, Italy, 00144
Pfizer Investigational Site	Not yet recruiting
Roma, Italy, 00165
Pfizer Investigational Site	Recruiting
Siena, Italy, 53100
South Africa
Pfizer Investigational Site	Recruiting
Cape Town, South Africa, 7925
Spain
Pfizer Investigational Site	Recruiting
Madrid, Spain, 28040
Pfizer Investigational Site	Not yet recruiting
Zaragoza, Spain, 50009
Sweden
Pfizer Investigational Site	Recruiting
Stockholm, Sweden, 171 76

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191193
Study First Received:	January 1, 2008
Last Updated:	February 1, 2010
ClinicalTrials.gov Identifier:	NCT00585312 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

FAP

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Adenomatous Polyposis Coli
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Adenomatous Polyps
Digestive System Neoplasms
Neoplasms by Histologic Type
Intestinal Polyposis

Celecoxib
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Intestinal Diseases
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Genetic Diseases, Inborn
Analgesics, Non-Narcotic
Gastrointestinal Neoplasms
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010