Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2007

Interventions

  • Drug: Celecoxib

Arms, Groups and Cohorts

  • Placebo Comparator: A

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer Inc
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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