Trials / Completed
CompletedNCT03237481
Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)
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 Open Inguinal Herniorrhaphy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 418 (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 unilateral open inguinal herniorrhaphy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HTX-011 | HTX 011 (bupivacaine/meloxicam), 300 mg/9 mg by instillation |
| DRUG | Bupivacaine HCl | Bupivacaine HCl without epinephrine, 75 mg by injection |
| DRUG | Saline placebo | Saline placebo by instillation |
| DEVICE | Luer-lock applicator | Applicator for instillation |
| DEVICE | Vial access device | Device for withdrawal of drug product |
Timeline
- Start date
- 2017-07-31
- Primary completion
- 2017-12-22
- Completion
- 2018-01-16
- First posted
- 2017-08-02
- Last updated
- 2026-03-02
- Results posted
- 2021-10-27
Locations
24 sites across 2 countries: United States, Belgium
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03237481. Inclusion in this directory is not an endorsement.