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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01755546 | Long-term Open-Label Safety Study to Evaluate EN3409 | PHASE3 | COMPLETED | 304 | — | — | Dec 1, 2012 | Nov 1, 2014 | Oct 18, 2018 | 57 | United States |
The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and the change from baseline at week 48 is presented.
| Arm | Type | Description |
|---|---|---|
| EN3409 | EXPERIMENTAL | Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily |
| Name | Type | Description |
|---|---|---|
| EN3409 | DRUG | Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily |
Inclusion Criteria: * Female subjects who are practicing abstinence or using a medically acceptable form of contraception or have been postmenopausal, biologically sterile, or surgically sterile for more than 1 year * Male subjects who are practicing abstinence, surgically sterile, or are using a m...