Trials / Completed
CompletedNCT04911062
HTX-011 in Spinal Surgery
A Phase 2, Two-Part, Multicenter Study of HTX-011 in Spinal Surgery
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Heron Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2, multicenter study in subjects undergoing an open lumbar decompression surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bupivacaine HCI without epinephrine | 100 mg administered via injection into the surgical site. |
| DRUG | HTX-011 | HTX-011 (bupivacaine/meloxicam) dose up to 200 mg/6 mg administered via application into the surgical site. |
| DEVICE | Luer Lock Applicator | Applicator for instillation. |
Timeline
- Start date
- 2022-04-07
- Primary completion
- 2022-07-29
- Completion
- 2022-08-26
- First posted
- 2021-06-02
- Last updated
- 2023-06-12
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04911062. Inclusion in this directory is not an endorsement.