A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP) (0966-205)(TERMINATED)

Adenomatous Polyposis Coli Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Rofecoxib in Familial Adenomatous Polyposis (FAP)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00140894
• Other study ID #: 0966-205
• Secondary ID: 2005_052
• Status: Terminated
• Phase: Phase 4
• Start date: August 6, 2002
• Est. completion date: October 11, 2004

Study information

• Verified date: September 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: October 11, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males or females at least 18 years of age with familial adenomatous polyposis.

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Colorectal Neoplasms
• Nasopharyngeal Neoplasms

Intervention

Drug:
• MK0966; rofecoxib / Duration of Treatment: 24 weeks

• Comparator: placebo / Duration of Treatment: 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and average size of rectal polyps
Primary	Safety and tolerability
Secondary	Number and average size of duodenal polyps
Secondary	Proportions of patients with improved overall colon rating