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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03295721 | Bunionectomy Study for Postoperative Analgesia (EPOCH 1) | PHASE3 | COMPLETED | 412 | — | — | Oct 24, 2017 | Mar 13, 2018 | Mar 2, 2026 | 15 | United States |
| NCT03237481 | Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2) | PHASE3 | COMPLETED | 418 | — | — | Jul 31, 2017 | Jan 16, 2018 | Mar 2, 2026 | 24 | United States, Belgium |
| NCT03718039 | Phase 2 Bunionectomy HTX-011 Administration Study | PHASE2 | COMPLETED | 78 | — | — | Oct 24, 2018 | Mar 11, 2019 | Mar 2, 2026 | 1 | United States |
| NCT03695367 | Phase 2 Herniorrhaphy Study for Opioid Elimination | PHASE2 | COMPLETED | 63 | — | — | Oct 1, 2018 | Dec 15, 2018 | Mar 2, 2026 | 5 | United States |
| NCT03011333 | Phase 2B Upper Extremity Nerve Block Study | PHASE2 | COMPLETED | 243 | — | — | Jan 14, 2017 | Mar 19, 2018 | Mar 2, 2026 | 2 | United States |
| NCT03015532 | Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia | PHASE2 | COMPLETED | 285 | — | — | Jan 13, 2017 | May 16, 2018 | Mar 2, 2026 | 24 | United States |
| NCT02504580 | Pilot Herniorrhaphy Study for Postoperative Analgesia | PHASE2 | COMPLETED | 463 | — | — | Jul 1, 2015 | Apr 1, 2017 | Mar 2, 2026 | 3 | United States |
Pain intensity is assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-72 is 0-720. The prescribed activity for NRS-A is sitting with the plantar surface of the ball of the surgically attended foot touching the floor (no weight bearing).
Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A), sitting with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).
Pain intensity is assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-24 is 0-240. The prescribed activity for NRS-A is keeping the elbows at the side and against the body and then raising both hands in front of the abdomen with hands clasped and holding that position for at least 5 seconds.
Pain intensity is assessed at rest using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-48 is 0-480.
Subjects assessed pain intensity for their current pain with the 11-point (0 to 10) Numeric Rating Scale NRS where "0" equated to "no pain" and "10" equated to "the worst pain imaginable". Pain intensity was assessed at rest (NRS-R) after the subject had been supine for a minimum of 5 minutes and with activity (NRS-A) sitting up from a supine position. The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 was 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 |
|---|---|---|
| Treatment Group 1: HTX-011 | EXPERIMENTAL | HTX 011 (bupivacaine/meloxicam) |
| Treatment Group 2: Saline Placebo | PLACEBO_COMPARATOR | Saline placebo |
| Treatment Group 3: Bupivacaine HCI | ACTIVE_COMPARATOR | Bupivacaine HCl |
| Treatment Group 2: Bupivacaine HCI | ACTIVE_COMPARATOR | Bupivacaine HCl |
| Treatment Group 3: Saline Placebo | PLACEBO_COMPARATOR | Saline placebo |
| Treatment Group 2: HTX-011 + Aprepitant | EXPERIMENTAL | HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally. |
| Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen | EXPERIMENTAL | HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen. |
| Cohort 1: HTX-011 + MMA Regimen | EXPERIMENTAL | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen. |
| Cohort 2: HTX-011 + MMA Regimen + Ketorolac | EXPERIMENTAL | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac. |
| Group 1: HTX-011 | EXPERIMENTAL | HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block. |
| Group 2: HTX-011 | EXPERIMENTAL | HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block. |
| Group 3: HTX-011 | EXPERIMENTAL | HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block. |
| Group 4: HTX-011 | EXPERIMENTAL | HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block. |
| Group 5: HTX-011 | EXPERIMENTAL | HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation. |
| Group 6: Bupivacaine HCl | ACTIVE_COMPARATOR | Bupivacaine HCl without epinephrine, 50 mg via nerve block. |
| Group 7: Saline Placebo | PLACEBO_COMPARATOR | Saline placebo via nerve block. |
| Cohort 1, Group 1: HTX-011 | EXPERIMENTAL | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation |
| Cohort 1, Group 2: HTX-011 | EXPERIMENTAL | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination) |
| Cohort 1, Group 3: Saline Placebo | PLACEBO_COMPARATOR | Saline placebo via injection |
| Cohort 1, Group 4: Bupivacaine HCI | ACTIVE_COMPARATOR | Bupivacaine HCl without epinephrine, 125 mg via injection |
| Cohort 2, Group 1: HTX-011 | EXPERIMENTAL | HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation |
| Cohort 2, Group 2: HTX-011 + Ropivacaine | EXPERIMENTAL | HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection |
| Cohort 2, Group 3: Saline Placebo | PLACEBO_COMPARATOR | Saline placebo via injection |
| Cohort 2, Group 4: Bupivacaine HCI | ACTIVE_COMPARATOR | Bupivacaine HCl without epinephrine, 125 mg via injection |
| Part A, Cohort A | EXPERIMENTAL | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg by injection. |
| Part A, Cohort B | EXPERIMENTAL | HTX-011(bupivacaine/meloxicam), 400 mg/12 mg by injection. |
| Part A, Cohort C | EXPERIMENTAL | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg by instillation. |
| Part A, Cohort D | EXPERIMENTAL | HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg by instillation. |
| Part A, Cohort E | EXPERIMENTAL | HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg by injection and instillation (combination). |
| Part A, Cohort F | PLACEBO_COMPARATOR | Saline placebo by injection. |
| Part B, Cohort A | EXPERIMENTAL | HTX-011A (bupivacaine/meloxicam), 200 mg/6 mg by injection. |
| Part B, Cohort B | EXPERIMENTAL | HTX-011A (bupivacaine/meloxicam) 400 mg12 mg by injection. |
| Part B, Cohort C | EXPERIMENTAL | HTX-011B (bupivacaine/meloxicam), 200 mg/6 mg by injection. |
| Part B, Cohort D | EXPERIMENTAL | HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg by injection. |
| Part B, Cohort E | PLACEBO_COMPARATOR | Saline placebo by injection. |
| Part C, Cohort A | EXPERIMENTAL | HTX-002, 200 mg by injection or instillation. |
| Part B, Cohort F | EXPERIMENTAL | HTX-002, 400 mg by injection or instillation. |
| Part C, Cohort B | EXPERIMENTAL | HTX-011B (bupivacaine/meloxicam), 200 mg/6 mg by instillation. |
| Part B, Cohort G | EXPERIMENTAL | HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg by instillation. |
| Part C, Cohort C | PLACEBO_COMPARATOR | Saline placebo by instillation. |
| Part C, Cohort D | ACTIVE_COMPARATOR | Bupivacaine HCI (Marcaine), 75 mg by injection. |
| Part D, Cohort A | EXPERIMENTAL | HTX-011B (bupivacaine/meloxicam), 400 mg/13 mg via a combination of injection and instillation. |
| Part E, Cohort A | EXPERIMENTAL | HTX-009, 12 mg by injection and instillation (combination). |
| Part F, Cohort A | EXPERIMENTAL | HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg by instillation. |
| Part F, Cohort B | EXPERIMENTAL | Bupivacaine HCI (Marcaine), 75 mg by injection. |
| Part F, Cohort C | PLACEBO_COMPARATOR | Saline placebo by injection. |
| Name | Type | Description |
|---|---|---|
| HTX-011 | DRUG | HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation |
| Saline Placebo | DRUG | Saline placebo by instillation |
| Bupivacaine HCl | DRUG | Bupivacaine HCl without epinephrine, 50 mg by injection |
| Luer-lock applicator | DEVICE | Applicator for instillation |
| Vial access device | DEVICE | Device for withdrawal of drug product |
| Luer Lock applicator | DEVICE | Applicator for instillation. |
| aprepitant | DRUG | Aprepitant, three single doses of aprepitant will be administered orally. |
| Ibuprofen | DRUG | Ibuprofen, 600 mg. |
| Acetaminophen | DRUG | Acetaminophen, 1 g. |
| Ketorolac | DRUG | Intraoperative IV ketorolac. |
| Bupivacaine HCl without epinephrine | DRUG | Bupivacaine HCl without epinephrine, 50 mg via nerve block. |
| Bupivicaine HCl | DRUG | Bupivacaine HCl without epinephrine |
| Ropivacaine | DRUG | Ropivacaine, via injection |
| Placebo | DRUG | Saline placebo by injection. |
| HTX-002 | DRUG | HTX-002, by injection or instillation (pooled). |
| Bupivacaine HCI (Marcaine) | DRUG | Bupivacaine HCI (Marcaine) by injection. |
| HTX-011A | DRUG | HTX-011A (bupivacaine/meloxicam) by injection. |
| HTX-011B | DRUG | HTX-011B (bupivacaine/meloxicam) by injection, instillation or combination. |
| HTX-009 | DRUG | HTX-009 by injection and instillation (combination). |
Inclusion Criteria: * Is scheduled to undergo a primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia. * Has an American Society of Anesthesiologists Physical Status of I, II, or III. * Female subjects are eligible only if not pregn...