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Trial record 14 of 40 for:    Familial Adenomatous Polyposis
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Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP) (CHIP)

This study is currently recruiting participants.
Verified June 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00585312
First received: January 1, 2008
Last updated: June 18, 2013
Last verified: June 2013
History of Changes
  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 3

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:

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 deleterious FAP genotype based on central genetic testing or personal history ot >2 colorectal adenomas and a parent with the diagnosis of FAP and either A, B or C below A: Non-attenuated FAP genotype B: Attenuated FAP genotype and a personal history of colorectal adenomas and a first degree relative with FAP C: No genotype identified with a personal history of > 2 adenomas and have a parent with FAP
  • Less than 30 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 in the absence of a personal history of >2 colorectal adenomas and a first degree relative (parent or sibling) with FAP.
  • Sensitivity to COX-2 inhibitors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585312

Contacts
Contact: Emergingmed 1-877-769-4832 faptrials@emergingmed.com
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 46 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

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: June 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
FAP

Additional relevant MeSH terms:
Adenomatous Polyposis Coli
Adenomatous Polyps
Intestinal Polyposis
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
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 June 18, 2013