Clinical trial NCT00141193: Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Adenoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 1561
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 3 years
Secondary outcomes:
measure: The number of colorectal adenomas in study subjects
timeFrame: 3 years
measure: the histopathologic grade of colorectal adenomas
timeFrame: 3 years
measure: the size of colorectal adenomas measured after one year and three years of study drug use.
timeFrame: 3 years
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Kiego
country: United States
facility: Pfizer Investigational Site
state: California
city: North Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Oak Park
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Townsville
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Geelong
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Abbotsford
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: St. John's
country: Canada
facility: Pfizer Investigational Site
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: Pfizer Investigational Site
city: Liberec
country: Czech Republic
facility: Pfizer Investigational Site
city: Prague 10
country: Czech Republic
facility: Pfizer Investigational Site
city: Prague 6
country: Czech Republic
facility: Pfizer Investigational Site
city: Prague
country: Czech Republic
facility: Pfizer Investigational Site
city: Prague
country: Czech Republic
facility: Pfizer Investigational Site
city: Arhus C
country: Denmark
facility: Pfizer Investigational Site
city: Oulu
country: Finland
facility: Pfizer Investigational Site
city: Bobigny
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Marseille Cedex 09
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 14
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Erlangen
country: Germany
facility: Pfizer Investigational Site
city: Freising
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Kuenzing
country: Germany
facility: Pfizer Investigational Site
city: Ludwigshafen
country: Germany
facility: Pfizer Investigational Site
city: Marburg
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Munchen
country: Germany
facility: Pfizer Investigational Site
city: Ulm
country: Germany
facility: Pfizer Investigational Site
city: Hong Kong
country: Hong Kong
facility: Pfizer Investigational Site
city: New Territories
country: Hong Kong
facility: Pfizer Investigational Site
city: Gyor
country: Hungary
facility: Pfizer Investigational Site
city: Szekszárd
country: Hungary
facility: Pfizer Investigational Site
city: Wilton
country: Ireland
facility: Pfizer Investigational Site
state: Cork
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Beer-Sheeva
country: Israel
facility: Pfizer Investigational Site
city: Hadera
country: Israel
facility: Pfizer Investigational Site
city: Haifa
country: Israel
facility: Pfizer Investigational Site
city: Hashomer
country: Israel
facility: Pfizer Investigational Site
city: Holon
country: Israel
facility: Pfizer Investigational Site
city: Jerusalem
country: Israel
facility: Pfizer Investigational Site
city: Petah-Tikva
country: Israel
facility: Pfizer Investigational Site
city: Tel-Aviv
country: Israel
facility: Pfizer Investigational Site
city: San Giovanni Rotondo
country: Italy
facility: Pfizer Investigational Site
state: Italy/Foggia/Italy
city: Brescia
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Maastricht
country: Netherlands
facility: Pfizer Investigational Site
city: Skien
country: Norway
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Warsaw
country: Poland
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
state: Western
city: Oviedo
country: Spain
facility: Pfizer Investigational Site
state: Asturias
city: San Sebastian
country: Spain
facility: Pfizer Investigational Site
state: Guipuzcoa
city: Palma de Mallorca
country: Spain
facility: Pfizer Investigational Site
state: Islas Baleares
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
city: Geneve 14
country: Switzerland
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Newport
country: United Kingdom
facility: Pfizer Investigational Site
state: Gwent
city: Harrow
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Oxford
country: United Kingdom
facility: Pfizer Investigational Site
city: Montevideo
country: Uruguay
facility: Pfizer Investigational Site
city: Montevideo
country: Uruguay
facility: Pfizer Investigational Site
city: Montevideo
country: Uruguay
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.