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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Rofecoxib

U.S. FDA Resources

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

Intervention Details:

Other Name: MK0966

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:	No

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:

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:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00060476 History of Changes
Other Study ID Numbers:	2006_414, Formally-P30A03LD, MK0966-201
Study First Received:	May 6, 2003
Last Updated:	November 2, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Rofecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012