Trials / Unknown
UnknownNCT05109312
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.
A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Different Surgical Procedures
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Heron Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bupivacaine Hydrochloride | 100 mg |
| DRUG | Bupivacaine Hydrochloride | 125 mg |
| DRUG | HTX-011 | 400 mg |
| DEVICE | Luer lock applicator | Applicator for instillation |
| DRUG | Ibuprofen | 400 mg |
| DRUG | Acetaminophen | 1 g |
Timeline
- Start date
- 2021-10-12
- Primary completion
- 2024-06-01
- Completion
- 2024-06-01
- First posted
- 2021-11-05
- Last updated
- 2023-10-26
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05109312. Inclusion in this directory is not an endorsement.