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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00140894

Enrollment

Registered

2005-09-01

Start date

2002-08-06

Completion date

2004-10-11

Last updated

2019-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomatous Polyposis Coli

Keywords

Osteoarthritis, Cancer Pain

Brief summary

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

Interventions

DRUGMK0966; rofecoxib / Duration of Treatment: 24 weeks

DRUGComparator: placebo / Duration of Treatment: 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Number and average size of rectal polyps	—
Safety and tolerability	—

Secondary

Measure	Time frame
Number and average size of duodenal polyps	—
Proportions of patients with improved overall colon rating	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026