Trials / Completed
CompletedNCT03695367
Phase 2 Herniorrhaphy Study for Opioid Elimination
A Phase 2, Open-Label Study of HTX 011 in a Multimodal Analgesic Regimen for Decreased Opioid Use Following Unilateral Open Inguinal Herniorrhaphy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- Heron Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal herniorrhaphy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HTX-011 | HTX-011 (bupivacaine/meloxicam), 300 mg/ 9 mg via instillation. |
| DEVICE | Luer lock applicator | Applicator for instillation. |
| DEVICE | Vial access device | Device for withdrawal of drug product. |
| DRUG | Ibuprofen | Ibuprofen, 600 mg. |
| DRUG | Acetaminophen | Acetaminophen, 1 g. |
| DRUG | Ketorolac | Intraoperative IV ketorolac. |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2018-11-20
- Completion
- 2018-12-15
- First posted
- 2018-10-04
- Last updated
- 2026-03-02
- Results posted
- 2021-07-02
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03695367. Inclusion in this directory is not an endorsement.