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Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

NCT00585312 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2021-02-21

Study results available
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Summary

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

Conditions

  • Adenomatous Polyposis Coli

Interventions

DRUG

Celecoxib

celecoxib, 16 mg/kg/day, for 5 years

DRUG

Placebo

Masked, placebo comparator

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00585312 on ClinicalTrials.gov