A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP)
A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis...
Brief Summary
Official Title: “A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Rofecoxib in Familial Adenomatous Polyposis (FAP)”
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: Merck Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00140894
