Back to resultsSafety and Efficacy of an Investigational Drug Versus Placebo in the Treatment of Cancer Pain (0663-083)
Primary Purpose
Bone Neoplasms
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0663, etoricoxib / Duration of Treatment: 4 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Bone Neoplasms focused on measuring Arcoxia
Eligibility Criteria
Inclusion Criteria: Patients are required to have a diagnosis of breast or prostate cancer with bone involvement and moderate to severe pain that requires opioid treatment.
Sites / Locations
Outcomes
Primary Outcome Measures
Analgesic efficacy over a 4 week treatment period; Safety and tolerability.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00095017
Brief Title
Safety and Efficacy of an Investigational Drug Versus Placebo in the Treatment of Cancer Pain (0663-083)
Official Title
A 4 Week Randomized, Placebo-Controlled, Parallel Group, Double-Blind Pilot Study to Assess the Safety and Efficacy of Etoricoxib 90 mg Versus Placebo in the Treatment of Cancer Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Neoplasms
Keywords
Arcoxia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0663, etoricoxib / Duration of Treatment: 4 weeks
Primary Outcome Measure Information:
Title
Analgesic efficacy over a 4 week treatment period; Safety and tolerability.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients are required to have a diagnosis of breast or prostate cancer with bone involvement and moderate to severe pain that requires opioid treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of an Investigational Drug Versus Placebo in the Treatment of Cancer Pain (0663-083)
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