Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

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NCT00585312

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Study Location
Pfizer Investigational Site
Chicago, Illinois, 60612, United States
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Contact
1-800-718-1021
[email protected]
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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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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.
Show details

- 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

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Adenomatous Polyposis ColiTrial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)
NCT00585312
  1. Chicago, Illinois
  2. Ann Arbor, Michigan
  3. Omaha, Nebraska
  4. New York, New York
  5. New York, New York
  6. New York, New York
  7. Chagrin Falls, Ohio
  8. Cincinnati, Ohio
  9. Cleveland, Ohio
  10. Cleveland, Ohio
  11. Elyria, Ohio
  12. Independence, Ohio
  13. Lakewood, Ohio
  14. Lorain, Ohio
  15. Solon, Ohio
  16. Strongsville, Ohio
  17. Westlake, Ohio
  18. Willoughby Hills, Ohio
  19. Wooster, Ohio
  20. Nashville, Tennessee
  21. Houston, Texas
  22. Salt Lake City, Utah
  23. Salt Lake City, Utah
  24. Bruxelles,
  25. Gent,
  26. Praha 5,
  27. Praha,
  28. Shatin, New Territories
  29. Hong Kong,
  30. Miskolc,
  31. Haifa,
  32. M.P. Lower Galilee,
  33. Petach Tikvah 49202,
  34. Tel Aviv,
  35. Roma,
  36. Siena,
  37. Rio Piedras,
  38. Bratislava,
  39. Cape Town, Western Cape, South africa
  40. Madrid,
  41. Stockholm,
  42. Donetsk,
  43. Harrow, Middlesex, England
ALL GENDERS
10 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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