Trials / Completed
CompletedNCT03295721
Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
A Phase 3, Randomized, Double Blind, Saline Placebo and Active Controlled, Multicenter Study of HTX 011 Via Local Administration for Postoperative Analgesia and Decreased Opioid Use Following Unilateral Simple Bunionectomy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 412 (actual)
- Sponsor
- Heron Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing bunionectomy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HTX-011 | HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation |
| DRUG | Saline Placebo | Saline placebo by instillation |
| DRUG | Bupivacaine HCl | Bupivacaine HCl without epinephrine, 50 mg by injection |
| DEVICE | Luer-lock applicator | Applicator for instillation |
| DEVICE | Vial access device | Device for withdrawal of drug product |
Timeline
- Start date
- 2017-10-24
- Primary completion
- 2018-01-08
- Completion
- 2018-03-13
- First posted
- 2017-09-28
- Last updated
- 2026-03-02
- Results posted
- 2021-10-27
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03295721. Inclusion in this directory is not an endorsement.