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