Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00060476
First received: May 6, 2003
Last updated: May 21, 2014
Last verified: May 2014
  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 3

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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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:
    Drug: rofecoxib
    Other Name: MK0966
    Drug: Comparator: placebo (unspecified)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00060476

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00060476     History of Changes
Other Study ID Numbers: 0966-201, Formally-P30A03LD, MK0966-201, 2006_414
Study First Received: May 6, 2003
Last Updated: May 21, 2014
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 July 22, 2014