study details
start date: September 2006
estimated completion: October 2013
last updated: November 3, 2014
phase of development: Phase 3
size / enrollment: 106
study design:
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
study 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.
primary outcomes:
- Time to Disease Progression [ Time Frame:5 years ] [ Designated as safety issue: No ]
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).
secondary outcomes:
- Time to Treatment Failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Time to treatment failure was defined as time from randomization to the earliest occurrence of one or more of the following:
1. Appearance of ≥20 polyps (>2 mm in size) at any colonoscopy during the study (Polyps), or
2. Diagnosis of colorectal malignancy (ColMal), or
3. 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.
inclusion criteria:
• Eligible Sexes:
- 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
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