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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02689258 | Evaluation of the Efficacy and Safety of HTX-011 for Postoperative Analgesia Following Abdominoplasty Surgery | PHASE2 | COMPLETED | 277 | — | — | Feb 23, 2016 | Apr 1, 2017 | Mar 2, 2026 | 8 | United States |
The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 will be calculated by summing the Pain intensity (PI) score at the relevant time points weighted by the scheduled time duration since the prior PI assessment as follows: SPI0-24= PI1+PI2+2\*PI4+2\*PI6+2\*PI8+2\*PI10+2\*PI12+2\*PI14+4\*PI18+6\*PI24. Min = 0 (if PI=0 at every time) and Max = 240 (if PI=10 at every time).
| Arm | Type | Description |
|---|---|---|
| Part A, Cohort A: HTX-011A | EXPERIMENTAL | HTX- 011A (bupivacaine/meloxicam), 200 mg/6 mg via injection |
| Parts A and B, Cohort B: Saline Placebo | PLACEBO_COMPARATOR | Saline placebo via injection |
| Part A, Cohort C: HTX-011B | EXPERIMENTAL | HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection |
| Part A, Cohort D: HTX-011B | EXPERIMENTAL | HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via injection |
| Part A, Cohort E: HTX-011B | EXPERIMENTAL | HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via combination |
| Part A, Cohort F: HTX-011B | EXPERIMENTAL | HTX- 011B (bupivacaine/meloxicam), 600 mg/18 mg via injection |
| Part B, Cohort A: HTX-002 | EXPERIMENTAL | HTX-002, 400 mg via combination |
| Part C, Cohort A: HTX-011B | EXPERIMENTAL | HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via instillation |
| Part C, Cohort B: HTX-011B | EXPERIMENTAL | HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via combination |
| Part C, Cohort C: HTX-011B | EXPERIMENTAL | HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg via combination |
| Part C, Cohort D: Bupivacaine HCI | ACTIVE_COMPARATOR | Bupivacaine HCl, 100 mg via injection |
| Part C, Cohort E: Saline Placebo | PLACEBO_COMPARATOR | Saline placebo via injection |
| Name | Type | Description |
|---|---|---|
| HTX-011B | DRUG | HTX- 011B (bupivacaine/meloxicam) via injection |
| Placebo | DRUG | Saline placebo via injection |
| HTX-011A | DRUG | HTX- 011A (bupivacaine/meloxicam) via injection |
| HTX-002 | DRUG | HTX-002 via combination |
| Bupivicaine HCl | DRUG | Bupivacaine HCl via injection |
Inclusion Criteria: Subjects must meet all of the following criteria to be considered eligible to participate in the study: 1. Be scheduled to undergo abdominoplasty surgery that is amenable to treatment with a long acting local anesthetic as per the anesthesia protocol 2. Be American Society of A...