Trial Review

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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
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
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St. John's
Country [16] 0 0
Chile
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RM
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China
State/province [17] 0 0
Beijing
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Czech Republic
State/province [18] 0 0
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
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Arhus C
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Finland
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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
State/province [34] 0 0
Kuenzing
Country [35] 0 0
Germany
State/province [35] 0 0
Ludwigshafen
Country [36] 0 0
Germany
State/province [36] 0 0
Marburg
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Germany
State/province [37] 0 0
Muenchen
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Germany
State/province [38] 0 0
Munchen
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Germany
State/province [39] 0 0
Ulm
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Hong Kong
State/province [40] 0 0
Hong Kong
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Hong Kong
State/province [41] 0 0
New Territories
Country [42] 0 0
Hungary
State/province [42] 0 0
Gyor
Country [43] 0 0
Hungary
State/province [43] 0 0
Szekszárd
Country [44] 0 0
Ireland
State/province [44] 0 0
Cork
Country [45] 0 0
Ireland
State/province [45] 0 0
Dublin
Country [46] 0 0
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
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Italy/Foggia/Italy
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Italy
State/province [55] 0 0
Brescia
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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
Country [62] 0 0
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
Country [66] 0 0
Slovakia
State/province [66] 0 0
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
State/province [70] 0 0
Guipuzcoa
Country [71] 0 0
Spain
State/province [71] 0 0
Islas Baleares
Country [72] 0 0
Spain
State/province [72] 0 0
Barcelona
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Spain
State/province [73] 0 0
Sevilla
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Sweden
State/province [74] 0 0
Stockholm
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Sweden
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Uppsala
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Switzerland
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Geneve 14
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Taiwan
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Kaohsiung
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United Kingdom
State/province [78] 0 0
Gwent
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United Kingdom
State/province [79] 0 0
Middlesex
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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00141193