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

August 5, 2008 updated by: Pfizer

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1561

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: A
Drug: Celecoxib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of colorectal adenomas in study subjects
Time Frame: 3 years
3 years
the histopathologic grade of colorectal adenomas
Time Frame: 3 years
3 years
the size of colorectal adenomas measured after one year and three years of study drug use.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

September 1, 2005

Study Record Updates

Last Update Posted (Estimate)

August 6, 2008

Last Update Submitted That Met QC Criteria

August 5, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EQ4-00-02-018
  • A3191107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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