| January 1, 2008 |
| February 26, 2010 |
| September 2006 |
| January 2019 (final data collection date for primary outcome measure) |
| To compare the time from randomization to treatment failure over a 5 year period in subjects treated with celecoxib vs placebo. [ Time Frame: 5 years ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00585312 on ClinicalTrials.gov Archive Site |
- To compare colorectal polyp burden over 5 years for subjects treated with celecoxib versus subjects treated with placebo. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To compare in the intent-to-treat population the time from randomization to treatment failure for subjects treated with celecoxib versus subjects treated with placebo [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To compare between subjects treated with celecoxib versus subjects treated with placebo the total number of colorectal polyps (>2 mm in size) detected over years 1-5 cumulatively. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|
- To compare in the intent-to-treat population the time from randomization to treatment failure for subjects treated with celecoxib versus subjects treated with placebo [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To compare between subjects treated with celecoxib versus subjects treated with placebo the total number of colorectal polyps (>2 mm in size) detected over years 1-5 cumulatively. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To compare colorectal polyp burden over 5 years for subjects treated with celecoxib versus subjects treated with placebo. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|
| |
| Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP) |
| A Phase III Placebo-Controlled Trial Of Celecoxib In Genotype Positive Subjects With Familial Adenomatous Polyposis |
To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP). |
| |
| Phase III |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Adenomatous Polyposis Coli |
- Drug: Celecoxib
celecoxib, 16 mg/kg/day, for 5 years
Other Name: celebrex, SC-58635
- Drug: Placebo
Masked, placebo comparator
|
- Celecoxib: Experimental
celecoxib, 16 mg/kg/day, for 5 years
Intervention: Drug: Celecoxib
- Placebo: Placebo Comparator
Masked, placebo comparator
Intervention: Drug: Placebo
|
| |
| |
| Recruiting |
| 200 |
| January 2019 |
| January 2019 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Age 10-17 years
- Confirmed non-attenuated FAP genotype based on central genetic testing
- Less than 20 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
- Sensitivity to COX-2 inhibitors
|
| Both |
| 10 Years to 17 Years |
| No |
|
|
| United States, Belgium, Czech Republic, Italy, Puerto Rico, South Africa, Spain, Sweden |
| |
| NCT00585312 |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| A3191193 |
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| February 2010 |
