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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 5, 2017
Last verified: May 2017
  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
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)

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 ]

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

Enrollment: 15000
Actual Study Start Date: January 8, 2003
Study Completion Date: December 8, 2004
Primary Completion Date: December 8, 2004 (Final data collection date for primary outcome measure)
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   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
Regular PSA testing and study biopsies required.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 5, 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

ClinicalTrials.gov processed this record on August 18, 2017