Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
NCT ID: NCT00141193
Last Updated: 2008-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1561 participants
INTERVENTIONAL
2001-02-28
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Celecoxib
Interventions
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Celecoxib
Eligibility Criteria
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Inclusion Criteria
* 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 inflammatory bowel disease.
30 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer Inc
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
San Diego, California, United States
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San Kiego, California, United States
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North Chicago, Illinois, United States
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Oak Park, Illinois, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Houston, Texas, United States
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Richmond, Virginia, United States
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Townsville, Queensland, Australia
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Geelong, Victoria, Australia
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Brussels, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Edmonton, Alberta, Canada
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Abbotsford, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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St. John's, , Canada
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Santiago, RM, Chile
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Beijing, , China
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Beijing, , China
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Brno, , Czechia
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Hradec Králové, , Czechia
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Liberec, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Arhus C, , Denmark
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Oulu, , Finland
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Bobigny, , France
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Lyon, , France
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Marseille, , France
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Paris, , France
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Berlin, , Germany
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Erlangen, , Germany
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Freising, , Germany
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Hamburg, , Germany
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Künzing, , Germany
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Ludwigshafen, , Germany
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Marburg, , Germany
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München, , Germany
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München, , Germany
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Ulm, , Germany
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Hong Kong, , Hong Kong
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New Territories, , Hong Kong
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Győr, , Hungary
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Szekszárd, , Hungary
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Wilton, Cork, Ireland
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Dublin, , Ireland
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Beer-Sheeva, , Israel
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Hadera, , Israel
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Haifa, , Israel
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Hashomer, , Israel
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Holon, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Tel Aviv, , Israel
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San Giovanni Rotondo, Italy/Foggia/Italy, Italy
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Brescia, , Italy
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Milan, , Italy
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Roma, , Italy
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Roma, , Italy
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Siena, , Italy
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Maastricht, , Netherlands
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Skien, , Norway
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Lima, Lima Province, Peru
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Warsaw, , Poland
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Lisbon, , Portugal
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Singapore, , Singapore
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Singapore, , Singapore
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Johannesburg, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Cape Town, Western, South Africa
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Palma de Mallorca, Balearic Islands, Spain
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Barcelona, Barcelona, Spain
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Donostia / San Sebastian, Guipuzcoa, Spain
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Oviedo, Principality of Asturias, Spain
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Seville, Sevilla, Spain
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Stockholm, , Sweden
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Uppsala, , Sweden
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Geneva, , Switzerland
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Kaohsiung City, , Taiwan
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Newport, Gwent, United Kingdom
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Harrow, Middlesex, United Kingdom
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Glasgow, , United Kingdom
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Oxford, , United Kingdom
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Montevideo, , Uruguay
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Montevideo, , Uruguay
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Montevideo, , Uruguay
Countries
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References
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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, Racz 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, 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. doi: 10.1056/NEJMoa061652.
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. doi: 10.1161/CIRCULATIONAHA.106.636746.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3191107
Identifier Type: -
Identifier Source: secondary_id
EQ4-00-02-018
Identifier Type: -
Identifier Source: org_study_id