Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00929188 | A Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Cancer-related Pain | PHASE2 | COMPLETED | 100 | — | — | Oct 1, 2009 | Jan 1, 2015 | Jan 22, 2016 | 40 | United States, France +3 |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | 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 |
| 002 | PLACEBO_COMPARATOR | Placebo Form=solution for injection route=subcutaneous use. SC injection (0.9 mL matching placebo) once on Day 1 |
| Name | Type | Description |
|---|---|---|
| JNJ-42160443 | DRUG | 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 |
| Placebo | DRUG | Form=solution for injection, route=subcutaneous use. SC injection (0.9 mL matching placebo) once on Day 1 |
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 sta...