NCT00060476

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for phase_3 prostate-cancer

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_3 prostate-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2004

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

May 6, 2003

Last Update Submit

May 5, 2017

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Time to prostate cancer

    Duration of Treatment

Secondary Outcomes (1)

  • Time to aggressive prostate cancer

    Duration of Treatment

Interventions

rofecoxibDRUG
Also known as: MK0966
Comparator: placebo (unspecified)DRUG

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Regular PSA testing and study biopsies required.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • 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. doi: 10.1185/030079907X219526.

    PMID: 17651539BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

rofecoxib

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2003

First Posted

May 7, 2003

Study Start

January 8, 2003

Primary Completion

December 8, 2004

Study Completion

December 8, 2004

Last Updated

May 9, 2017

Record last verified: 2017-05