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Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

Last updated on December 7, 2019

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Study Location
Pfizer Investigational Site
San Diego, California, 92123 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Adenoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- The subject has a history of Familial Adenomatous Polyposis or Hereditary
Non-Polyposis Colorectal Cancer.

- The subject has a history of inflammatory bowel disease.

NCT00141193
Pfizer
Completed
Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

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Descriptive Information
Brief Title  ICMJE Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
Official Title  ICMJE 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)
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Adenoma
Intervention  ICMJE Drug: Celecoxib
Study Arms  ICMJE Placebo Comparator: A
Intervention: Drug: Celecoxib
Publications *


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2007)
1561
Original Enrollment  ICMJE
 (submitted: August 30, 2005)
1500
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion DateMay 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   Chile,   China,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   Netherlands,   Norway,   Peru,   Poland,   Portugal,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States,   Uruguay
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00141193
Other Study ID Numbers  ICMJE EQ4-00-02-018
A3191107
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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