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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00293033 | Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects | PHASE3 | COMPLETED | 152 | — | — | Feb 1, 2006 | Apr 1, 2007 | Nov 18, 2019 | 1 | United States |
Pain intensity (using an 11-point \[0 = no pain to 10 = worst pain\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| BEMA™ Fentanyl | EXPERIMENTAL | BioErodible MucoAdhesive (BEMA) Fentanyl |
| Name | Type | Description |
|---|---|---|
| BEMA™ | DRUG | BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) Fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small soluble film that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the film readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the film are water soluble, so the entire dosage form dissolves within 30 minutes of application. |
| Placebo | DRUG | - |
Inclusion Criteria: * Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she is using an acceptable method of birth control. * 18 years or older * Patient must have pain associated with cancer or cancer treatment. * Patient...