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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00060476

Enrollment

15000

Registered

2003-05-07

Start date

2003-01-08

Completion date

2004-12-08

Last updated

2017-05-09

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

Conditions

Prostate Cancer

Brief summary

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

Detailed description

The duration of treatment is 6 years.

Interventions

DRUGrofecoxib

DRUGComparator: placebo (unspecified)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

50 Years to 75 Years

Healthy volunteers

Inclusion criteria

Regular PSA testing and study biopsies required.

Design outcomes

Primary

Measure	Time frame
Time to prostate cancer	Duration of Treatment

Secondary

Measure	Time frame
Time to aggressive prostate cancer	Duration of Treatment

Outcome results

None listed

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