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

Study Timeline

• Study Start: 2002-08-06
• Study Completion: 2004-10-11
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-20

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