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

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ClinicalTrials.gov Identifier: NCT00060476
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: rofecoxib Drug: Comparator: placebo (unspecified) Phase 3

Detailed Description:
The duration of treatment is 6 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Actual Study Start Date : January 8, 2003
Actual Primary Completion Date : December 8, 2004
Actual Study Completion Date : December 8, 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources


Intervention Details:
    Drug: rofecoxib
    Other Name: MK0966
    Drug: Comparator: placebo (unspecified)


Primary Outcome Measures :
  1. Time to prostate cancer [ Time Frame: Duration of Treatment ]

Secondary Outcome Measures :
  1. Time to aggressive prostate cancer [ Time Frame: Duration of Treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
Regular PSA testing and study biopsies required.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060476


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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

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
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents