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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - Celecoxib

Placebo Comparator: A -


Treatment: Drugs: Celecoxib
Intervention code [1] 0 0
Treatment: Drugs
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
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Belgium
State/province [9] 0 0
Gent
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Brazil
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RS
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Brazil
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SP
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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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
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Czech Republic
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Hradec Kralove
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Czech Republic
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Liberec
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Czech Republic
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Prague 10
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Czech Republic
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Prague 6
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Czech Republic
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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
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Marseille Cedex 09
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France
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Paris Cedex 14
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Germany
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Berlin
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Germany
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Erlangen
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Germany
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Freising
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Germany
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Hamburg
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Germany
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Kuenzing
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Germany
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Ludwigshafen
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Germany
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Marburg
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Germany
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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
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Gyor
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Hungary
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Szekszárd
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Ireland
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Cork
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Ireland
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Dublin
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Israel
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Beer-Sheeva
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Israel
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Hadera
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Israel
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Haifa
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Israel
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Hashomer
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Petah-Tikva
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Israel
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Tel-Aviv
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Italy
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Italy/Foggia/Italy
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Italy
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Brescia
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Italy
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Milano
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Italy
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Roma
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Italy
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Siena
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Netherlands
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Maastricht
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Norway
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Skien
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Peru
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Lima
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Poland
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Warsaw
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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
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South Africa
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Gauteng
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South Africa
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Western
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Spain
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Asturias
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Spain
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Guipuzcoa
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Spain
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Islas Baleares
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Spain
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Barcelona
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Spain
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Sevilla
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Sweden
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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
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Gwent
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United Kingdom
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Middlesex
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United Kingdom
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Glasgow
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United Kingdom
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Oxford
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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/ct2/show/NCT00141193
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