Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2013-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Adenomatous Polyposis Coli

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Celecoxib

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

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

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

Placebo

Masked, placebo comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Masked, placebo comparator

Interventions

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Celecoxib

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

Intervention Type DRUG

Placebo

Masked, placebo comparator

Intervention Type DRUG

Other Intervention Names

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celebrex, SC-58635

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No