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Trial record 1 of 1 for:    NCT00585312
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Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP) (CHIP)

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ClinicalTrials.gov Identifier: NCT00585312
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : January 3, 2008
Results First Posted : November 2, 2014
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE January 1, 2008
First Posted Date  ICMJE January 3, 2008
Results First Submitted Date  ICMJE October 28, 2014
Results First Posted Date  ICMJE November 2, 2014
Last Update Posted Date February 21, 2021
Study Start Date  ICMJE September 2006
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2014)
Time to Disease Progression [ Time Frame: 5 years ]
Time to disease progression was defined as the time from randomization to the earliest occurrence of one or more of the following events:
  1. Appearance of ≥20 polyps (>2 mm in size) at any colonoscopy during the study (Polyps); or
  2. Diagnosis of colorectal malignancy (ColMal).
Original Primary Outcome Measures  ICMJE
 (submitted: January 1, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2014)
  • Time to Treatment Failure [ Time Frame: 5 years ]
    Time to treatment failure was defined as time from randomization to the earliest occurrence of one or more of the following:
    • Appearance of ≥20 polyps (>2 mm in size) at any colonoscopy during the study (Polyps), or
    • Diagnosis of colorectal malignancy (ColMal), or
    • Treatment related dropout (DO). The treatment related dropout was defined as insufficient clinical response, progression of disease, death, adverse event, treatment-related laboratory abnormality, subject no longer willing to participate in study, and other reasons that might be related to treatment as determined by treating physicians in a blind fashion before database release.
  • Total Number of Colorectal Polyps [ Time Frame: Years 1 - 5 ]
    Total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5 cumulatively. Weighted total number of colorectal polyps over Years 1 - 5 cumulatively was defined as the total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5, divided by the number of colonoscopies that the participant had during the study.
  • Colorectal Polyp Burden [ Time Frame: Years 1 - 5 ]
    The polyp burden was defined as the sum of the largest diameters of all polyps (>2 mm in size) over Years 1 - 5 cumulatively. Weighted colorectal polyp burden over Years 1 - 5 cumulatively was defined as the polyp burden over Years 1 - 5 divided by the number of colonoscopies that the participant had during the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 1, 2008)
  • 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 ]
  • To compare colorectal polyp burden over 5 years for subjects treated with celecoxib versus subjects treated with placebo. [ Time Frame: 5 years ]
  • 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<br>1-5 cumulatively. [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Per 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 Date October 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,   Czechia,   Hong Kong,   Hungary,   Israel,   Italy,   Puerto Rico,   Slovakia,   South Africa,   Spain,   Sweden,   Ukraine,   United Kingdom,   United States
Removed Location Countries Chile,   Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00585312
Other Study ID Numbers  ICMJE A3191193
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2021

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