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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00696137 | Long-term Extension Study of BEMA™ Fentanyl | PHASE3 | COMPLETED | 5 | — | — | Jun 1, 2008 | Jul 1, 2009 | Sep 24, 2019 | - | — |
Efficacy was not measured in this study as the intention was to evaluate long term safety in this population. The number of deaths in the long term follow-up will be reported.
| Arm | Type | Description |
|---|---|---|
| BEMA Fentanyl | EXPERIMENTAL | BEMA Fentanyl |
| Name | Type | Description |
|---|---|---|
| BEMA Fentanyl | DRUG | buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily |
Inclusion Criteria: 1. previously qualified for and participated in study FEN-202 for at least 2 weeks, 2. wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and 3. provide signed informed consent at screening prior to any study procedures. Exclusion Criteria: 1. th...