NCT00929188

A Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Cancer-related Pain

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Cancer-Related Pain, Followed by an Open-Label Extension Phase

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and effectiveness of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe cancer-related pain in terminally ill patients with a diagnosis of active cancer.

Detailed description

This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned drug) study to evaluate the safety and effectiveness of JNJ-42160443 compared with placebo in the treatment of men and women 18 years of age or older who are terminally ill (ie, patients who are in or who are candidates for hospice or palliative \[other medical care\] care for end-of-life management) with moderate to severe, chronic, cancer-related pain that is not controlled by standard pain medications and who have a diagnosis of active cancer. The duration of the study will be approximately 62 weeks (includes screening, the 4-week double-blind phase followed by the 48-week open-label \[study doctor and patient knows the name of the assigned treatment\] extension phase and a posttreatment phase). A single dose of JNJ-42160443 or matching placebo given as an (subcutaneous \[SC\]) injection under the skin during the double-blind treatment period. During the open-label period, JNJ-42160443 will be given once every 4 weeks for up to 48 weeks.

Conditions

• Pain, Burning
• Pain, Crushing
• Pain, Migratory
• Pain, Radiating
• Pain, Splitting

Interventions

Type	Name	Description
DRUG	JNJ-42160443	Type=1, unit=mg, number=10, form=solution for injection , route=subcutaneous use. SC injection (10mg/ml) once every 4 weeks for up to 52 weeks
DRUG	Placebo	Form=solution for injection, route=subcutaneous use. SC injection (0.9 mL matching placebo) once on Day 1

Timeline

• Start date: 2009-10-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2009-06-26
• Last updated: 2016-01-22

Locations

40 sites across 5 countries: United States, France, Poland, Portugal, Spain