Clinical Trial: A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Rofecoxib in Familial Adenomatous Polyposis (FAP)

Brief Summary: A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Number and average size of rectal polyps
  • Safety and tolerability


Original Primary Outcome:

Current Secondary Outcome:

  • Number and average size of duodenal polyps
  • Proportions of patients with improved overall colon rating


Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: August 30, 2005
Date Started: March 2003
Date Completion:
Last Updated: November 30, 2006
Last Verified: November 2006