Treatment With MK0966 for the Prevention of Prostate Cancer

Verified by: Merck, November 2009
First Received: May 6, 2003 | Last Updated: November 2, 2009 | Phase: Phase 3 | Start Date: June 2003
Overall Status: Completed | Estimated Enrollment: 15000
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To determine the efficacy and safety of an investigational compound (MK0966) for the prevention of prostate cancer...

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)”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

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?: No

Clinical Trial Investigator Information

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Related Publications

References

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.

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00060476