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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02762929 | Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy | PHASE2 | COMPLETED | 430 | — | — | May 1, 2016 | Mar 1, 2017 | Feb 23, 2026 | 5 | 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 |
|---|---|---|
| HTX-011A: 200 mg | EXPERIMENTAL | HTX-011A (bupivacaine/meloxicam), 200 mg/6 mg via injection. |
| HTX-011B: 30 mg | EXPERIMENTAL | HTX 011B (bupivacaine/meloxicam), 30 mg/0.9 mg via injection. |
| HTX-011B : 60 mg | EXPERIMENTAL | HTX-011B (bupivacaine/meloxicam) 60 mg/1.8 mg via injection or instillation. |
| HTX-011B: 120 mg | EXPERIMENTAL | HTX- 011B (bupivacaine/meloxicam), 120 mg/3.6 mg via injection or instillation. |
| HTX-011B: 200 mg | EXPERIMENTAL | HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection. |
| Bupivacaine HCI | ACTIVE_COMPARATOR | Bupivacaine HCI, 50 mg via injection. |
| Saline Placebo | ACTIVE_COMPARATOR | Saline placebo via injection. |
| HTX-002, 60 mg | EXPERIMENTAL | HTX- 002, 60 mg via injection. |
| HTX-002, 120 mg | EXPERIMENTAL | HTX-002, 120 mg via injection. |
| HTX-002, 200 mg | EXPERIMENTAL | HTX-002, 200 mg via injection. |
| HTX-009 | EXPERIMENTAL | HTX-009, 3.6 mg via injection. |
| Name | Type | Description |
|---|---|---|
| HTX-011A | DRUG | HTX-011A (bupivacaine/meloxicam), via injection. |
| Saline Placebo | BIOLOGICAL | Saline placebo via injection. |
| HTX-011B | DRUG | HTX-011B (bupivacaine/meloxicam), via injection or instillation. |
| HTX-002 | DRUG | HTX-002, via injection. |
| Bupivacaine HCl | DRUG | Bupivacaine HCI, via injection. |
| HTX-009 | DRUG | HTX-009, via injection. |
Inclusion Criteria: 1. Be male or female 18 years of age or older 2. Female subjects are eligible only if all of the following apply: 1. Not pregnant (female subject of child bearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test before surger...