drugset / Trial / NCT05109312
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical procedures. Each parallel cohort will enroll subjects undergoing a unique surgical procedure: total shoulder arthroplasty (TSA) in Cohort 1 and abdominoplasty in Cohort 2.
Timeline
- Start
- 2021-10-12
- Primary completion
- 2024-06
- Completion
- 2024-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 100 mg | — |
| Comparator | Bupivacaine | Other / unclassified | 125 mg | — |
| Subject | HTX-011 | Unknown | 400 mg | — |
| Background | Acetaminophen | Small molecule | 1 g | — |
| Background | Ibuprofen | Small molecule | 400 mg | — |
Indications
No indication recorded.