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NCT00095017 Clinical Trial

Safety and Efficacy of an Investigational Drug Versus Placebo in the Treatment of Cancer Pain (0663-083)

Bone Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00095017
Other study ID # 0663-083
Secondary ID 2004_090
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date November 2004

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0663, etoricoxib / Duration of Treatment: 4 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary Analgesic efficacy over a 4 week treatment period; Safety and tolerability.
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