Treatment With MK0966 for the Prevention of Prostate Cancer - Full Text View

Purpose

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

Condition	Intervention	Phase
Prostate Cancer	Drug: rofecoxib Drug: Comparator: placebo (unspecified)	Phase III

MedlinePlus related topics:

Cancer Prostate Cancer

Drug Information available for:

Rofecoxib

U.S. FDA Resources

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

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)

Further study details as provided by Merck:

Primary Outcome Measures:

Time to prostate cancer [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to aggressive prostate cancer [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]

Enrollment:	15000
Study Start Date:	June 2003
Study Completion Date:	February 2005

Detailed Description:

The duration of treatment is 6 years.

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Regular PSA testing and study biopsies required.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060476

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Publications indexed to this study:

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.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_414, Formally-P30A03LD, MK0966-201
First Received:	May 6, 2003
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00060476
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Rofecoxib

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Cyclooxygenase Inhibitors

Physiological Effects of Drugs

Enzyme Inhibitors

Cyclooxygenase 2 Inhibitors

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00060476