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Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
This study has been completed.
First Received: August 30, 2005   Last Updated: August 5, 2008   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00141193
  Purpose

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.


Condition Intervention Phase
Colorectal Adenoma
 Drug: Celecoxib
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

Drug Information available for: Celecoxib
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1561
Study Start Date: February 2001
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Placebo Comparator Drug: Celecoxib

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141193

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
San Diego, California, United States, 92123
Pfizer Investigational Site
San Kiego, California, United States, 92123
United States, Illinois
Pfizer Investigational Site
North Chicago, Illinois, United States, 60064
Pfizer Investigational Site
Oak Park, Illinois, United States, 60304
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Baltimore, Maryland, United States, 21229
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19107-5244
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23249
Australia, Queensland
Pfizer Investigational Site
Townsville, Queensland, Australia, 4812
Australia, Victoria
Pfizer Investigational Site
Geelong, Victoria, Australia, 3219
Belgium
Pfizer Investigational Site
Gent, Belgium, 9000
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Pfizer Investigational Site
Brussels, Belgium, 1090
Pfizer Investigational Site
Bruxelles, Belgium, 1200
Brazil, RS
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90035-003
Brazil, SP
Pfizer Investigational Site
São Paulo, SP, Brazil, 01509-900
Canada
Pfizer Investigational Site
St. John's, Canada, A1B 3V6
Canada, Alberta
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z 1J3
Pfizer Investigational Site
Abbotsford, British Columbia, Canada, V2S 3N5
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada, N6A 4G5
Pfizer Investigational Site
Kingston, Ontario, Canada, K7L 5G2
Chile, RM
Pfizer Investigational Site
Santiago, RM, Chile
China
Pfizer Investigational Site
Beijing, China, 10053
Pfizer Investigational Site
Beijing, China, 100730
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic
Pfizer Investigational Site
Hradec Kralove, Czech Republic, 500 12
Pfizer Investigational Site
Prague 6, Czech Republic, 16 02
Pfizer Investigational Site
Prague 10, Czech Republic, 10034
Pfizer Investigational Site
Prague, Czech Republic
Pfizer Investigational Site
Prague, Czech Republic, 11833
Pfizer Investigational Site
Liberec, Czech Republic, 460 63
Denmark
Pfizer Investigational Site
Arhus C, Denmark, 8000
Finland
Pfizer Investigational Site
Oulu, Finland, FIN-90221
France
Pfizer Investigational Site
PARIS CEDEX 14, France, 75679
Pfizer Investigational Site
BOBIGNY, France, 93009
Pfizer Investigational Site
LYON, France, 69008
Pfizer Investigational Site
MARSEILLE CEDEX 09, France, 13274
Germany
Pfizer Investigational Site
Hamburg, Germany
Pfizer Investigational Site
Marburg, Germany, 35055
Pfizer Investigational Site
Ludwigshafen, Germany, 67063
Pfizer Investigational Site
Freising, Germany, 85356
Pfizer Investigational Site
Berlin, Germany, 13353
Pfizer Investigational Site
Ulm, Germany, 89081
Pfizer Investigational Site
Munchen, Germany, 81675
Pfizer Investigational Site
Muenchen, Germany, 81669
Pfizer Investigational Site
Erlangen, Germany, 91052
Pfizer Investigational Site
Kuenzing, Germany, 94550
Hong Kong
Pfizer Investigational Site
New Territories, Hong Kong
Pfizer Investigational Site
Hong Kong, Hong Kong
Hungary
Pfizer Investigational Site
Gyor, Hungary, 9023
Pfizer Investigational Site
Szekszárd, Hungary, 7100
Ireland
Pfizer Investigational Site
Dublin, Ireland
Ireland, Cork
Pfizer Investigational Site
Wilton, Cork, Ireland
Israel
Pfizer Investigational Site
Hashomer, Israel, 52621
Pfizer Investigational Site
Jerusalem, Israel, 91120
Pfizer Investigational Site
Tel-Aviv, Israel, 64239
Pfizer Investigational Site
Haifa, Israel
Pfizer Investigational Site
Beer-Sheeva, Israel, 84101
Pfizer Investigational Site
Petah-Tikva, Israel
Pfizer Investigational Site
Hadera, Israel, 38100
Pfizer Investigational Site
Holon, Israel, 58100
Italy
Pfizer Investigational Site
Brescia, Italy, 25123
Pfizer Investigational Site
Roma, Italy, 00144
Pfizer Investigational Site
Milano, Italy, 20141
Pfizer Investigational Site
Siena, Italy, 53100
Pfizer Investigational Site
Roma, Italy, 00153
Italy, Italy/Foggia/Italy
Pfizer Investigational Site
San Giovanni Rotondo, Italy/Foggia/Italy, Italy, 71013
Netherlands
Pfizer Investigational Site
Maastricht, Netherlands, 6229 HX
Norway
Pfizer Investigational Site
Skien, Norway, 3710
Peru
Pfizer Investigational Site
Lima, Peru, L11
Pfizer Investigational Site
Lima, Peru, L11
Poland
Pfizer Investigational Site
Warsaw, Poland, 02-781
Portugal
Pfizer Investigational Site
Lisboa, Portugal, 1099-023
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 123154
Pfizer Investigational Site
Moscow, Russian Federation, 129356
Pfizer Investigational Site
Moscow, Russian Federation, 117415
Pfizer Investigational Site
Moscow, Russian Federation, 103006
Pfizer Investigational Site
Moscow, Russian Federation, 113093
Pfizer Investigational Site
Moscow, Russian Federation, 115478
Singapore
Pfizer Investigational Site
Singapore, Singapore, 119074
Pfizer Investigational Site
Singapore, Singapore, 529889
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia
Pfizer Investigational Site
Bratislava, Slovakia, 85107
South Africa, Gauteng
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa, 2157
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa, 2193
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa
South Africa, Western
Pfizer Investigational Site
Cape Town, Western, South Africa, 7708
Spain
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
Sevilla, Spain, 41071
Spain, Asturias
Pfizer Investigational Site
Oviedo, Asturias, Spain, 33006
Spain, Guipuzcoa
Pfizer Investigational Site
San Sebastian, Guipuzcoa, Spain, 20014
Spain, Islas Baleares
Pfizer Investigational Site
Palma de Mallorca, Islas Baleares, Spain, 07014
Sweden
Pfizer Investigational Site
Uppsala, Sweden, 75185 Uppala
Pfizer Investigational Site
Stockholm, Sweden, 116 91 Stockholm
Switzerland
Pfizer Investigational Site
Geneve 14, Switzerland, 1211
Taiwan
Pfizer Investigational Site
Kaohsiung, Taiwan, 813
United Kingdom
Pfizer Investigational Site
Glasgow, United Kingdom, G40SF
Pfizer Investigational Site
Oxford, United Kingdom, OX3 9DU
United Kingdom, Gwent
Pfizer Investigational Site
Newport, Gwent, United Kingdom, NP9 2UB
United Kingdom, Middlesex
Pfizer Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
Uruguay
Pfizer Investigational Site
Montevideo, Uruguay, 11600
Pfizer Investigational Site
Montevideo, Uruguay, 1200
Pfizer Investigational Site
Montevideo, Uruguay
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site
Link to ClinicalStudyResults.org Posting  This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
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.

Responsible Party: Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: EQ4-00-02-018, A3191107
Study First Received: August 30, 2005
Last Updated: August 5, 2008
ClinicalTrials.gov Identifier: NCT00141193     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Celecoxib
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Sensory System Agents
 Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Adenoma
Adenomatous Polyps
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009



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