A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis...
Date First Received: August 30, 2005
Last Updated: November 30, 2006
Verified by: Merck, November 2006
Clinical Trial Phase: Phase 4 | Start Date: March 2003
Overall Status: Terminated
Estimated Enrollment: 62
Brief Summary
Official Title: “A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Rofecoxib in Familial Adenomatous Polyposis (FAP)”
Condition Keyword(s):
A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0966; rofecoxib / Duration of Treatment: 24 weeks
- Drug: Comparator: placebo / Duration of Treatment: 24 weeks
Outcome Measures for this Clinical Trial
Primary Measures
- Number and average size of rectal polyps
- Safety and tolerability
Secondary Measures
- Number and average size of duodenal polyps
- Proportions of patients with improved overall colon rating
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Males or females at least 18 years of age with familial adenomatous polyposis.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00140894
Study ID Number: 2005_052
ClinicalTrials.gov Identifier: NCT00140894
Health Authority: Canada: Health Canada
Clinical Trials Authorship and Review
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