Trials / Completed
CompletedNCT03974932
Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen
A Phase 3b, Open-Label Study of HTX-011 as Part of a Scheduled Non-Opioid Multimodal Analgesic Regimen in Subjects Undergoing Total Knee Arthroplasty
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- Heron Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase 3b, open-label single-arm study in which all subjects receive HTX-011 as part of a scheduled non-opioid MMA regimen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HTX-011 | Dual-acting local anesthetic. Dose 1. |
| DRUG | Ibuprofen | NSAID. |
| DRUG | Acetaminophen | Analgesic. |
| DRUG | Celecoxib | NSAID. |
| DRUG | +/- Bupivacaine HCl | Local anesthetic. |
| DEVICE | Luer Lock Applicator | Applicator for instillation. |
| DRUG | HTX-011 | Dual-acting local anesthetic. Dose 2. |
Timeline
- Start date
- 2019-06-05
- Primary completion
- 2020-12-07
- Completion
- 2021-01-07
- First posted
- 2019-06-05
- Last updated
- 2026-03-02
- Results posted
- 2023-08-31
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03974932. Inclusion in this directory is not an endorsement.