Trials / Completed
CompletedNCT03907176
Herniorrhaphy Study for Opioid Elimination
A Phase 3b, Randomized, Open-Label Study of HTX-011 as the Foundation of a Non-opioid, Multimodal Analgesic Regimen to Decrease Opioid Use Following Unilateral Open Inguinal Herniorrhaphy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 115 (actual)
- Sponsor
- Heron Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of HTX-011 and a postoperative non-opioid multimodal analgesic (MMA) regimen. The study will be conducted in 2 sequential parts: Part 1 is randomized and Part 2 is Investigator's preference for MMA regimen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HTX-011 | 300 mg |
| DEVICE | Luer lock applicator | Applicator for instillation |
| DRUG | Ibuprofen | 600 mg |
| DRUG | Acetaminophen | 1 g |
Timeline
- Start date
- 2019-04-05
- Primary completion
- 2021-10-25
- Completion
- 2021-11-22
- First posted
- 2019-04-08
- Last updated
- 2022-02-21
Locations
30 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03907176. Inclusion in this directory is not an endorsement.