Trials / Completed
CompletedNCT04398329
Dose-Escalation Study of HTX-034 Following Bunionectomy
A Phase 1b/2, Randomized, Blinded, Active-Controlled Study of Escalating Doses of HTX-034 for Postoperative Analgesia in Subjects Undergoing Unilateral, First Metatarsal Bunionectomy With Osteotomy and Internal Fixation
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- Heron Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b will evaluate escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 will be a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b compared with bupivacaine HCl.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HTX-034 | HTX-034, low dose |
| DRUG | HTX-034 | HTX-034, high dose |
| DEVICE | Luer lock applicator | Applicator for instillation |
| DRUG | Bupivacaine HCl | Bupivacaine HCl, 50 mg |
Timeline
- Start date
- 2020-05-18
- Primary completion
- 2021-07-01
- Completion
- 2021-08-03
- First posted
- 2020-05-21
- Last updated
- 2022-02-15
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04398329. Inclusion in this directory is not an endorsement.