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

Trial Information

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

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.