| 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) |
| 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. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment |
| Colorectal Adenoma |
| Drug: Celecoxib |
| Placebo Comparator: A
Intervention: Drug: Celecoxib
|
- Arber N, Lieberman D, Wang TC, Zhang R, Sands GH, Bertagnolli MM, Hawk ET, Eagle C, Coindreau J, Zauber A, Lanas A, Levin B. The APC and PreSAP trials: a post hoc noninferiority analysis using a comprehensive new measure for gastrointestinal tract injury in 2 randomized, double-blind studies comparing celecoxib and placebo. Clin Ther. 2012 Mar;34(3):569-79. doi: 10.1016/j.clinthera.2012.02.001. Epub 2012 Mar 2.
- Arber N, Spicak J, Rácz I, Zavoral M, Breazna A, Gerletti P, Lechuga MJ, Collins N, Rosenstein RB, Eagle CJ, Levin B. Five-year analysis of the prevention of colorectal sporadic adenomatous polyps trial. Am J Gastroenterol. 2011 Jun;106(6):1135-46. doi: 10.1038/ajg.2011.116. Epub 2011 Apr 19.
- Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E; Cross Trial Safety Assessment Group. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008 Apr 22;117(16):2104-13. doi: 10.1161/CIRCULATIONAHA.108.764530. Epub 2008 Mar 31.
- Arber N, Eagle CJ, Spicak J, Rácz I, Dite P, Hajer J, Zavoral M, Lechuga MJ, Gerletti P, Tang J, Rosenstein RB, Macdonald K, Bhadra P, Fowler R, Wittes J, Zauber AG, Solomon SD, Levin B; PreSAP Trial Investigators. Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med. 2006 Aug 31;355(9):885-95.
- Solomon SD, Pfeffer MA, McMurray JJ, Fowler R, Finn P, Levin B, Eagle C, Hawk E, Lechuga M, Zauber AG, Bertagnolli MM, Arber N, Wittes J; APC and PreSAP Trial Investigators. Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas. Circulation. 2006 Sep 5;114(10):1028-35.
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| |
| Completed |
| 1561 |
| May 2007 |
| May 2007 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- The subject has had a documented colonoscopy to the cecum performed by a study-related physician with adequate preparation resulting in diagnosis and clearance of an adenomatous polyp(s) within 4 months prior to randomization.
- The subject is willing to abstain from chronic use of all NSAIDs or COX-2 inhibitors excluding aspirin at cardioprotective doses for the duration of the study.
Exclusion Criteria:
- The subject has a history of Familial Adenomatous Polyposis or Hereditary Non-Polyposis Colorectal Cancer.
- The subject has a history of inflammatory bowel disease.
|
| Sexes Eligible for Study: |
All |
|
| 30 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States, Uruguay |
| |
| |
| NCT00141193 |
EQ4-00-02-018
A3191107 |
| Yes |
| Not Provided |
| Not Provided |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| August 2008 |
