Trials / Terminated
TerminatedNCT00585312
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 10 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Celecoxib | celecoxib, 16 mg/kg/day, for 5 years |
| DRUG | Placebo | Masked, placebo comparator |
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2013-10-01
- Completion
- 2013-10-01
- First posted
- 2008-01-03
- Last updated
- 2021-02-21
- Results posted
- 2014-11-03
Locations
42 sites across 14 countries: United States, Belgium, Czechia, Hong Kong, Hungary, Israel, Italy, Puerto Rico, Slovakia, South Africa, Spain, Sweden, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00585312. Inclusion in this directory is not an endorsement.