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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01298765 | Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain | PHASE3 | COMPLETED | 302 | — | — | Mar 1, 2011 | Aug 1, 2012 | Aug 7, 2018 | 26 | 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 used to calculate the change from baseline at week 52.
| Arm | Type | Description |
|---|---|---|
| BEMA Buprenorphine | EXPERIMENTAL | buprenorphine buccal soluble film |
| Name | Type | Description |
|---|---|---|
| BEMA Buprenorphine | DRUG | buccal soluble film; applied to the buccal mucosa twice daily |
Inclusion Criteria: * Male or non-pregnant and non-nursing female aged 18 or older * History of moderate to severe chronic pain: 1. Subjects completing study BUP-301 (low back pain) or 2. Osteoarthritis or neuropathic pain, or subjects not completing study BUP-301 (low back pain), pain for ≥3 ...