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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00141193




Registration number
NCT00141193
Ethics application status
Date submitted
30/08/2005
Date registered
1/09/2005
Date last updated
6/08/2008

Titles & IDs
Public title
Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
Scientific 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)
Secondary ID [1] 0 0
A3191107
Secondary ID [2] 0 0
EQ4-00-02-018
Universal Trial Number (UTN)
Trial acronym
PRESAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Adenoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Placebo comparator: A -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
The number of colorectal adenomas in study subjects
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
the histopathologic grade of colorectal adenomas
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
the size of colorectal adenomas measured after one year and three years of study drug use.
Timepoint [3] 0 0
3 years

Eligibility
Key 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.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2007
Sample size
Target
Accrual to date
Final
1561
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Townsville
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Geelong
Recruitment postcode(s) [1] 0 0
4812 - Townsville
Recruitment postcode(s) [2] 0 0
3219 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Belgium
State/province [7] 0 0
Brussels
Country [8] 0 0
Belgium
State/province [8] 0 0
Bruxelles
Country [9] 0 0
Belgium
State/province [9] 0 0
Gent
Country [10] 0 0
Brazil
State/province [10] 0 0
RS
Country [11] 0 0
Brazil
State/province [11] 0 0
SP
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
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Canada
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British Columbia
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Canada
State/province [14] 0 0
Ontario
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Canada
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St. John's
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Chile
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RM
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China
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Beijing
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Czech Republic
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Brno
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Hradec Kralove
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Liberec
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Prague 10
Country [22] 0 0
Czech Republic
State/province [22] 0 0
Prague 6
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Prague
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Denmark
State/province [24] 0 0
Arhus C
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Finland
State/province [25] 0 0
Oulu
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France
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Bobigny
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France
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Lyon
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France
State/province [28] 0 0
Marseille Cedex 09
Country [29] 0 0
France
State/province [29] 0 0
Paris Cedex 14
Country [30] 0 0
Germany
State/province [30] 0 0
Berlin
Country [31] 0 0
Germany
State/province [31] 0 0
Erlangen
Country [32] 0 0
Germany
State/province [32] 0 0
Freising
Country [33] 0 0
Germany
State/province [33] 0 0
Hamburg
Country [34] 0 0
Germany
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Kuenzing
Country [35] 0 0
Germany
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Ludwigshafen
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Germany
State/province [36] 0 0
Marburg
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Germany
State/province [37] 0 0
Muenchen
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Germany
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Munchen
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Germany
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Ulm
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Hong Kong
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Hong Kong
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Hong Kong
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New Territories
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Hungary
State/province [42] 0 0
Gyor
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Hungary
State/province [43] 0 0
Szekszárd
Country [44] 0 0
Ireland
State/province [44] 0 0
Cork
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Ireland
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Dublin
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Israel
State/province [46] 0 0
Beer-Sheeva
Country [47] 0 0
Israel
State/province [47] 0 0
Hadera
Country [48] 0 0
Israel
State/province [48] 0 0
Haifa
Country [49] 0 0
Israel
State/province [49] 0 0
Hashomer
Country [50] 0 0
Israel
State/province [50] 0 0
Holon
Country [51] 0 0
Israel
State/province [51] 0 0
Jerusalem
Country [52] 0 0
Israel
State/province [52] 0 0
Petah-Tikva
Country [53] 0 0
Israel
State/province [53] 0 0
Tel-Aviv
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Italy
State/province [54] 0 0
Italy/Foggia/Italy
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Italy
State/province [55] 0 0
Brescia
Country [56] 0 0
Italy
State/province [56] 0 0
Milano
Country [57] 0 0
Italy
State/province [57] 0 0
Roma
Country [58] 0 0
Italy
State/province [58] 0 0
Siena
Country [59] 0 0
Netherlands
State/province [59] 0 0
Maastricht
Country [60] 0 0
Norway
State/province [60] 0 0
Skien
Country [61] 0 0
Peru
State/province [61] 0 0
Lima
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Poland
State/province [62] 0 0
Warsaw
Country [63] 0 0
Portugal
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Lisboa
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Russian Federation
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Moscow
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Singapore
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Singapore
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Slovakia
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Bratislava
Country [67] 0 0
South Africa
State/province [67] 0 0
Gauteng
Country [68] 0 0
South Africa
State/province [68] 0 0
Western
Country [69] 0 0
Spain
State/province [69] 0 0
Asturias
Country [70] 0 0
Spain
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Guipuzcoa
Country [71] 0 0
Spain
State/province [71] 0 0
Islas Baleares
Country [72] 0 0
Spain
State/province [72] 0 0
Barcelona
Country [73] 0 0
Spain
State/province [73] 0 0
Sevilla
Country [74] 0 0
Sweden
State/province [74] 0 0
Stockholm
Country [75] 0 0
Sweden
State/province [75] 0 0
Uppsala
Country [76] 0 0
Switzerland
State/province [76] 0 0
Geneve 14
Country [77] 0 0
Taiwan
State/province [77] 0 0
Kaohsiung
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Gwent
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Middlesex
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Glasgow
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Oxford
Country [82] 0 0
Uruguay
State/province [82] 0 0
Montevideo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00141193
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00141193