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Trial record 1 of 1 for:    NCT00141193
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Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP) (PRESAP)

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ClinicalTrials.gov Identifier: NCT00141193
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : August 6, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 30, 2005
First Posted Date  ICMJE September 1, 2005
Last Update Posted Date August 6, 2008
Study Start Date  ICMJE February 2001
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • The number of colorectal adenomas in study subjects [ Time Frame: 3 years ]
  • the histopathologic grade of colorectal adenomas [ Time Frame: 3 years ]
  • the size of colorectal adenomas measured after one year and three years of study drug use. [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
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. In addition, the type, incidence, severity, timing, seriousnes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 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.
Detailed Description Not 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 Date May 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 Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP