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Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP) (PRESAP)

Primary Purpose

Colorectal Adenoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Celecoxib
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Adenoma

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

A

Arm Description

Outcomes

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.

Secondary Outcome Measures

The number of colorectal adenomas in study subjects
the histopathologic grade of colorectal adenomas
the size of colorectal adenomas measured after one year and three years of study drug use.

Full Information

First Posted
August 30, 2005
Last Updated
August 5, 2008
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00141193
Brief Title
Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
Acronym
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

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1561 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The number of colorectal adenomas in study subjects
Time Frame
3 years
Title
the histopathologic grade of colorectal adenomas
Time Frame
3 years
Title
the size of colorectal adenomas measured after one year and three years of study drug use.
Time Frame
3 years

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
22386831
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.
Results Reference
derived
PubMed Identifier
21503000
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.
Results Reference
derived
PubMed Identifier
18378608
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.
Results Reference
derived
PubMed Identifier
16943401
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.
Results Reference
derived
PubMed Identifier
16943394
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=EQ4-00-02-018&StudyName=Prevention%20of%20Colorectal%20Sporadic%20Adenomatous%20Polyps%20%28PRESAP%29
Description
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Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

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