| August 30, 2005 |
| August 5, 2008 |
| February 2001 |
| May 2007 (final data collection date for primary outcome measure) |
| To evaluate the effects of celecoxib in reducing the proportion of subjects with new colorectal adenomas post baseline polypectomy after Month 13 (Year 1) and Month 37 (Year 3) of study drug administration. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ] |
| To evaluate the effects of celecoxib in reducing the proportion of subjects with new colorectal adenomas post baseline polypectomy after Month 13 (Year 1) and Month 37 (Year 3) of study drug administration. |
| Complete list of historical versions of study NCT00141193 on ClinicalTrials.gov Archive Site |
- The number of colorectal adenomas in study subjects [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- the histopathologic grade of colorectal adenomas [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- the size of colorectal adenomas measured after one year and three years of study drug use. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|
| The number of colorectal adenomas in study subjects the histopathologic grade of colorectal adenomas the size of colorectal adenomas measured after one year and three years of study drug use. In addition, the type, incidence, severity, timing, seriousnes |
| |
| 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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Colorectal Adenoma |
| Drug: Celecoxib |
| |
- 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. Epub 2008 Mar 31.
- Arber N, Eagle CJ, Spicak J, Racz 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.
|
| |
| 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.
|
| Both |
| 30 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, 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, Uruguay |
| |
| NCT00141193 |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| EQ4-00-02-018, A3191107 |
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| August 2008 |
