Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

NCT00141193 | Completed Phase 3 DMC

• 2 other identifiers: EQ4-00-02-018A3191107
• Study Type: interventional
• Target: 1,561
• Locations: 32 countries
• Sites: 106

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.

Conditions

Colorectal Adenoma

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (3)

• The number of colorectal adenomas in study subjects

  3 years

• the histopathologic grade of colorectal adenomas

  3 years

• the size of colorectal adenomas measured after one year and three years of study drug use.

  3 years

Study Arms (1)

A

PLACEBO COMPARATOR

Drug: Celecoxib

Interventions

Celecoxib DRUG

A

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The subject has a history of Familial Adenomatous Polyposis or Hereditary Non-Polyposis Colorectal Cancer.
• The subject has a history of inflammatory bowel disease.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (106)

Pfizer Investigational Site

San Diego, California, 92123, United States

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San Kiego, California, 92123, United States

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North Chicago, Illinois, 60064, United States

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Oak Park, Illinois, 60304, United States

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Baltimore, Maryland, 21229, United States

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Baltimore, Maryland, United States

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Philadelphia, Pennsylvania, 19107-5244, United States

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Philadelphia, Pennsylvania, 19107, United States

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Houston, Texas, 77030, United States

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Richmond, Virginia, 23249, United States

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Townsville, Queensland, 4812, Australia

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Geelong, Victoria, 3219, Australia

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Brussels, 1070, Belgium

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Brussels, 1090, Belgium

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Brussels, 1200, Belgium

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Ghent, 9000, Belgium

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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

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São Paulo, São Paulo, 01509-900, Brazil

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Edmonton, Alberta, T6G 2B7, Canada

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Abbotsford, British Columbia, V2S 3N5, Canada

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Vancouver, British Columbia, V5Z 1J3, Canada

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Vancouver, British Columbia, V6Z 1Y6, Canada

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Kingston, Ontario, K7L 5G2, Canada

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London, Ontario, N6A 4G5, Canada

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St. John's, A1B 3V6, Canada

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Santiago, RM, Chile

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Beijing, 10053, China

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Beijing, 100730, China

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Brno, Czechia

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Hradec Králové, 500 12, Czechia

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Liberec, 460 63, Czechia

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Prague, 10034, Czechia

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Prague, 11833, Czechia

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Prague, 16 02, Czechia

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Prague, Czechia

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Arhus C, 8000, Denmark

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Oulu, FIN-90221, Finland

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Bobigny, 93009, France

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Lyon, 69008, France

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Marseille, 13274, France

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Paris, 75679, France

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Berlin, 13353, Germany

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Erlangen, 91052, Germany

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Freising, 85356, Germany

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Hamburg, Germany

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Künzing, 94550, Germany

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Ludwigshafen, 67063, Germany

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Marburg, 35055, Germany

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München, 81669, Germany

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München, 81675, Germany

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Ulm, 89081, Germany

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Hong Kong, Hong Kong

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New Territories, Hong Kong

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Győr, 9023, Hungary

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Szekszárd, 7100, Hungary

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Wilton, Cork, Ireland

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Dublin, Ireland

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Beer-Sheeva, 84101, Israel

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Hadera, 38100, Israel

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Haifa, Israel

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Hashomer, 52621, Israel

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Holon, 58100, Israel

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Jerusalem, 91120, Israel

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Petah Tikva, Israel

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Tel Aviv, 64239, Israel

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San Giovanni Rotondo, Italy/Foggia/Italy, 71013, Italy

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Brescia, 25123, Italy

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Milan, 20141, Italy

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Roma, 00144, Italy

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Roma, 00153, Italy

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Siena, 53100, Italy

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Maastricht, 6229 HX, Netherlands

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Skien, 3710, Norway

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Lima, Lima Province, L11, Peru

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Warsaw, 02-781, Poland

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Lisbon, 1099-023, Portugal

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Moscow, 103006, Russia

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Moscow, 113093, Russia

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Moscow, 115478, Russia

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Moscow, 117415, Russia

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Moscow, 123154, Russia

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Moscow, 129356, Russia

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Singapore, 119074, Singapore

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Singapore, 529889, Singapore

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Bratislava, 85107, Slovakia

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Bratislava, Slovakia

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Johannesburg, Gauteng, 2157, South Africa

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Johannesburg, Gauteng, 2193, South Africa

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Johannesburg, Gauteng, South Africa

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Cape Town, Western, 7708, South Africa

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Palma de Mallorca, Balearic Islands, 07014, Spain

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Barcelona, Barcelona, 08036, Spain

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Donostia / San Sebastian, Guipuzcoa, 20014, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Seville, Sevilla, 41071, Spain

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Stockholm, 116 91 Stockholm, Sweden

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Uppsala, 75185 Uppala, Sweden

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Geneva, 1211, Switzerland

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Kaohsiung City, 813, Taiwan

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Newport, Gwent, NP9 2UB, United Kingdom

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Harrow, Middlesex, HA1 3UJ, United Kingdom

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Glasgow, G40SF, United Kingdom

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Oxford, OX3 9DU, United Kingdom

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Montevideo, 11600, Uruguay

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Montevideo, 1200, Uruguay

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Montevideo, Uruguay

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Related Publications (5)

• 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.

  PMID: 22386831 DERIVED

• 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.

  PMID: 21503000 DERIVED

• 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.

  PMID: 18378608 DERIVED

• 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.

  PMID: 16943401 DERIVED

• 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.

  PMID: 16943394 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: February 1, 2001
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: August 6, 2008

Record last verified: 2008-08

Locations

IL (8); NL (1); FI (1); CH (1); CL (1); UR (3); HK (2); CA (7); NO (1); DK (1); IE (2); PT (1); AU (2); IT (6); RU (6); GB (4); PL (1); DE (10); ZA (4); BR (2); ES (5); SG (2); TW (1); PE (1); CZ (7); FR (4); HU (2); US (10); CN (2); BE (4); SL (2); SE (2)