Trials / Completed
CompletedNCT00141193
Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
Clinical Protocol For a Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Celecoxib (SC-58635) In The Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,561 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
Summary
This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Celecoxib |
Timeline
- Start date
- 2001-02-01
- Primary completion
- 2007-05-01
- Completion
- 2007-05-01
- First posted
- 2005-09-01
- Last updated
- 2008-08-06
Locations
106 sites across 32 countries: United States, Australia, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Peru, Poland, Portugal, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Uruguay
Source: ClinicalTrials.gov record NCT00141193. Inclusion in this directory is not an endorsement.