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Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

Last updated on November 8, 2019

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Study Location
Pfizer Investigational Site
Chicago, Illinois, 60612 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Adenomatous Polyposis Coli
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00585312
Pfizer
Terminated
Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

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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 SummaryTo test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).
Detailed DescriptionPer DMC recommendation, the study was terminated early (31Oct2013) due to low enrollment and low endpoint accumulation rate. No safety concerns were involved in the decision to terminate the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Adenomatous Polyposis Coli
Intervention  ICMJE
  • Drug: Celecoxib
    celecoxib, 16 mg/kg/day, for 5 years
    Other Name: celebrex, SC-58635
  • Drug: Placebo
    Masked, placebo comparator
Study Arms  ICMJE
  • Experimental: Celecoxib
    celecoxib, 16 mg/kg/day, for 5 years
    Intervention: Drug: Celecoxib
  • Placebo Comparator: Placebo
    Masked, placebo comparator
    Intervention: Drug: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 3, 2014)
106
Original Estimated Enrollment  ICMJE
 (submitted: January 1, 2008)
200
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion DateOctober 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czech Republic,   Hong Kong,   Hungary,   Israel,   Italy,   Puerto Rico,   Slovakia,   South Africa,   Spain,   Sweden,   Ukraine,   United Kingdom,   United States
Removed Location CountriesChile
 
Administrative Information
NCT Number  ICMJE NCT00585312
Other Study ID Numbers  ICMJE A3191193
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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