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Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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
• Start date: November 2004

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• 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• Status: Withdrawn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
• 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.

Related Conditions & MeSH terms

• Bone Neoplasms
• Cancer Pain

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.