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A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP)
study id #: NCT00140894
condition: Adenomatous Polyposis Coli
A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.
Drug: MK0966; rofecoxib / Duration of Treatment: 24 weeks
Drug: Comparator: placebo / Duration of Treatment: 24 weeks
start date: March 2003
estimated completion: Not Available
last updated: November 30, 2006
phase of development: Phase 4
size / enrollment: 62
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
- Number and average size of rectal polyps
- Safety and tolerability
- Number and average size of duodenal polyps
- Proportions of patients with improved overall colon rating
- Males or females at least 18 years of age with familial adenomatous polyposis.
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