drugset / Trial / NCT06109415
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.
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 Total Shoulder Arthroplasty (TSA) (Cohort 1).
Timeline
- Start
- 2021-10-20
- Primary completion
- 2022-07-18
- Completion
- 2022-07-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 100 mg | — |
| Subject | HTX-011 | Unknown | 400 mg | — |
| Background | Acetaminophen | Small molecule | 1 g | — |
| Background | Ibuprofen | Small molecule | 400 mg | — |
Indications
No indication recorded.