Clinical Trial: Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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

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 Summary:
Sponsor: Pfizer

Current Primary Outcome: 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: 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.

Current Secondary Outcome:

  • 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: 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

Information By: Pfizer

Dates:
Date Received: August 30, 2005
Date Started: February 2001
Date Completion:
Last Updated: August 5, 2008
Last Verified: August 2008