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

 -  Terminally ill cancer patients as per judgment of the investigator (eg, patients who
 are in or who are candidates for hospice or palliative care for end-of-life
 management); Diagnosis of moderate to severe pain directly related to an active cancer
 that is not controlled by standard pain treatments.

 Exclusion Criteria:Planned major surgical procedures during the double-blind treatment
 phase that may affect study outcomes; Prior treatment with any other investigational NGF
 inhibitor therapy; Known allergies, hypersensitivity, or intolerance to JNJ-42160443 or its
 excipients; Enrolled in any investigational study within the previous 4 weeks or 5
 half-lives of the investigational drug (whichever is longer), or are currently enrolled in
 another investigational study at the time of screening