| Original Study ID : 2006_414 |
| Secondary ID : Array |
| NCT ID : NCT00060476 |
| Brief Title : Treatment With MK0966 for the Prevention of Prostate Cancer |
| 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) |
| Brief Summary :
To determine the efficacy and safety of an investigational compound (MK0966) for the
prevention of prostate cancer.
|
| Source : Merck |
| Detailed Description :
The duration of treatment is 6 years.
|
| Overall Status : Completed |
| Start Date : June 2003 |
| End Date : February 2005 |
| Completion Date : February 2005 |
| Official Title : Phase 3 |
| Phase : Interventional |
| Study Design : Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Enrollment : 15000 |
| Verification Date : May 2009 |
| First Received Date : May 6, 2003 |
| Trial Eligibility |
Criteria :
Regular PSA testing and study biopsies required.
|
| Gender : Male |
| Minimum Age : 50 Years |
| Maximum Age : 75 Years |
| Healthy Volunteers : Accepts He |
| Refferances |
| PMID : 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. |
| OutComes |
| Primary OutComes |
| Measure : Time to prostate cancer |
| Time Frame : Duration of Treatment |
| Safety issue : No |
|
| Secondary OutComes |
| Measure : Time to aggressive prostate cancer |
| Time Frame : Duration of Treatment |
| Safety issue : No |
|
| Interventions |
| Type : Drug |
| Name : rofecoxib |
|
| Type : Drug |
| Name : Comparator: placebo (unspecified) |
|
