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

Sponsor:	Pfizer
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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
Experimental: Celecoxib celecoxib, 16 mg/kg/day, for 5 years	Drug: Celecoxib celecoxib, 16 mg/kg/day, for 5 years Other Name: celebrex, SC-58635
Placebo Comparator: Placebo 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: Emergingmed	1-877-769-4832	faptrials@emergingmed.com

Show 43 Study Locations

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

Pediatric FAP Clinical Trial Information Service This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00585312 History of Changes
Obsolete Identifiers:	NCT00393016, NCT00534040
Other Study ID Numbers:	A3191193
Study First Received:	January 1, 2008
Last Updated:	December 25, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

FAP

Additional relevant MeSH terms:

Adenomatous Polyposis Coli
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases

Colonic Diseases
Intestinal Diseases
Intestinal Polyposis
Genetic Diseases, Inborn
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012