Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)

May 5, 2017 updated by: Merck Sharp & Dohme LLC

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Rofecoxib in Decreasing the Risk of Prostate Cancer (ViP Study)

To determine the efficacy and safety of an investigational compound (MK0966) for the prevention of prostate cancer.

Study Overview

Status

Completed

Conditions

Prostate Cancer

Intervention / Treatment

Detailed Description

The duration of treatment is 6 years.

Study Type

Interventional

Enrollment (Actual)

15000

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

Regular PSA testing and study biopsies required.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to prostate cancer Time Frame: Duration of Treatment	Duration of Treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to aggressive prostate cancer Time Frame: Duration of Treatment	Duration of Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

van Adelsberg J, Gann P, Ko AT, Damber JE, Logothetis C, Marberger M, Schmitz-Drager BJ, Tubaro A, Harms CJ, Roehrborn C. The VIOXX in Prostate Cancer Prevention study: cardiovascular events observed in the rofecoxib 25 mg and placebo treatment groups. Curr Med Res Opin. 2007 Sep;23(9):2063-70. doi: 10.1185/030079907X219526.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2003

Primary Completion (Actual)

December 8, 2004

Study Completion (Actual)

December 8, 2004

Study Registration Dates

First Submitted

May 6, 2003

First Submitted That Met QC Criteria