Back to resultsTreatment With MK0966 for the Prevention of Prostate Cancer (0966-201)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
rofecoxib
Comparator: placebo (unspecified)
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer
Eligibility Criteria
Regular PSA testing and study biopsies required.
Sites / Locations
Outcomes
Primary Outcome Measures
Time to prostate cancer
Secondary Outcome Measures
Time to aggressive prostate cancer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00060476
Brief Title
Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 8, 2003 (Actual)
Primary Completion Date
December 8, 2004 (Actual)
Study Completion Date
December 8, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15000 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
rofecoxib
Other Intervention Name(s)
MK0966
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo (unspecified)
Primary Outcome Measure Information:
Title
Time to prostate cancer
Time Frame
Duration of Treatment
Secondary Outcome Measure Information:
Title
Time to aggressive prostate cancer
Time Frame
Duration of Treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Regular PSA testing and study biopsies required.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17651539
Citation
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.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)
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