NCT00095017

Brief Summary

The purpose of this study is to compare the effectiveness of an investigational drug versus placebo in the treatment of metastatic bone cancer pain in patients diagnosed with breast or prostate cancer and a bone neoplasm. Patients in the study will be taking opioids to treat moderate to severe pain for their bone metastases and will remain on their opioids during the entire course of the study.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2004

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2004

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

First QC Date

October 29, 2004

Last Update Submit

February 4, 2022

Conditions

Bone Neoplasms

Keywords

Arcoxia

Outcome Measures

Primary Outcomes (1)

  • Analgesic efficacy over a 4 week treatment period; Safety and tolerability.

Interventions

MK0663, etoricoxib / Duration of Treatment: 4 weeksDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients are required to have a diagnosis of breast or prostate cancer with bone involvement and moderate to severe pain that requires opioid treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bone Neoplasms

Interventions

EtoricoxibDuration of Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2004

First Posted

November 1, 2004

Study Start

November 1, 2004

Last Updated

February 16, 2022

Record last verified: 2022-02