Treatment With MK0966 for the Prevention of Prostate Cancer

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

Date First Received: May 6, 2003

Last Updated: July 31, 2008

Verified by: Merck, July 2008

Clinical Trial Phase: Phase 3 | Start Date: June 2003

Overall Status: Completed

Estimated Enrollment: 15000

Brief Summary

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

Condition Keyword(s):

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

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Detailed Clinical Trial Description

The duration of treatment is 6 years.

Intervention(s) in this Clinical Trial

  • Drug: rofecoxib
  • Drug: Comparator: placebo (unspecified)

Outcome Measures for this Clinical Trial

Primary Measures

  • Time to prostate cancer
    • Time Frame: Duration of Treatment
      Safety Issue?: No

Secondary Measures

  • Time to aggressive prostate cancer
    • Time Frame: Duration of Treatment
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

  • Regular PSA testing and study biopsies required.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Sponsor Information

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Additional Information

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00060476

Study ID Number: 2006_414

ClinicalTrials.gov Identifier: NCT00060476

Health Authority: United States: Food and Drug Administration

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