A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP) (0966-205)(TERMINATED)
Phase 4
Terminated
- Conditions
- Adenomatous Polyposis Coli
- Registration Number
- NCT00140894
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
- Males or females at least 18 years of age with familial adenomatous polyposis.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number and average size of rectal polyps Safety and tolerability
- Secondary Outcome Measures
Name Time Method Number and average size of duodenal polyps Proportions of patients with improved overall colon rating
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie rofecoxib's efficacy in familial adenomatous polyposis (FAP)?
How does rofecoxib compare to standard-of-care treatments for FAP-related adenomas in terms of effectiveness and safety?
Are there specific biomarkers that predict response to rofecoxib in patients with Adenomatous Polyposis Coli?
What are the known adverse events associated with rofecoxib use in FAP patients and how are they managed?
What related compounds or combination therapies have been explored for FAP treatment alongside rofecoxib?