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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00585312
Other study ID # A3191193
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 2006
Est. completion date October 2013

Study information

Verified date February 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).


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.


Other known NCT identifiers
  • NCT00393016
  • NCT00534040

Recruitment information / eligibility

Status Terminated
Enrollment 106
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender All
Age group 10 Years to 17 Years
Eligibility 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

Study Design


Intervention

Drug:
Celecoxib
celecoxib, 16 mg/kg/day, for 5 years
Placebo
Masked, placebo comparator

Locations

Country Name City State
Belgium Pfizer Investigational Site Bruxelles
Belgium Pfizer Investigational Site Gent
Czechia Pfizer Investigational Site Praha
Czechia Pfizer Investigational Site Praha 5
Hong Kong Pfizer Investigational Site Hong Kong
Hong Kong Pfizer Investigational Site Shatin New Territories
Hungary Pfizer Investigational Site Miskolc
Israel Pfizer Investigational Site Haifa
Israel Pfizer Investigational Site M.P. Lower Galilee
Israel Pfizer Investigational Site Petach Tikvah 49202
Israel Pfizer Investigational Site Tel Aviv
Italy Pfizer Investigational Site Roma
Italy Pfizer Investigational Site Siena
Puerto Rico Pfizer Investigational Site Rio Piedras
Slovakia Pfizer Investigational Site Bratislava
South Africa Pfizer Investigational Site Cape Town Western Cape, South Africa
Spain Pfizer Investigational Site Madrid
Sweden Pfizer Investigational Site Stockholm
Ukraine Pfizer Investigational Site Donetsk
United Kingdom Pfizer Investigational Site Harrow, Middlesex England
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Chagrin Falls Ohio
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Elyria Ohio
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Independence Ohio
United States Pfizer Investigational Site Lakewood Ohio
United States Pfizer Investigational Site Lorain Ohio
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site Solon Ohio
United States Pfizer Investigational Site Strongsville Ohio
United States Pfizer Investigational Site Westlake Ohio
United States Pfizer Investigational Site Willoughby Hills Ohio
United States Pfizer Investigational Site Wooster Ohio

Sponsors (1)

Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Hong Kong,  Hungary,  Israel,  Italy,  Puerto Rico,  Slovakia,  South Africa,  Spain,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Disease Progression Time to disease progression was defined as the time from randomization to the earliest occurrence of one or more of the following events:
Appearance of =20 polyps (>2 mm in size) at any colonoscopy during the study (Polyps); or
Diagnosis of colorectal malignancy (ColMal).
5 years
Secondary Time to Treatment Failure 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.
5 years
Secondary Total Number of Colorectal Polyps 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.
Years 1 - 5
Secondary Colorectal Polyp Burden 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.
Years 1 - 5
See also
  Status Clinical Trial Phase
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Completed NCT05014360 - A Study of JNJ-64251330 in Participants With Familial Adenomatous Polyposis Phase 1
Completed NCT01604564 - Registry With Information About Colitis Ulcerosa and Familial Adenomatous Polyposis Patients
Recruiting NCT05919264 - FOG-001 in Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT02113202 - Molecular Fluorescence Endoscopy in Patients With Familial Adenomatous Polyposis, Using Bevacizumab-IRDye800CW Phase 1
Withdrawn NCT03027401 - Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics
Recruiting NCT06435533 - Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis N/A
Terminated NCT00140894 - A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP) (0966-205)(TERMINATED) Phase 4
Active, not recruiting NCT01187901 - A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients Phase 2
Recruiting NCT00319007 - Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis Phase 2
No longer available NCT04948398 - Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis