drugset / Trial / NCT04398329
Dose-Escalation Study of HTX-034 Following Bunionectomy
RandomizedParallel-groupTriple-blindPrevention
Summary
This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 was a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b, compared with bupivacaine HCl.
Timeline
- Start
- 2020-05-08
- Primary completion
- 2021-07-15
- Completion
- 2021-07-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aprepitant | Other / unclassified | 4.3 mg | — |
| Subject | Aprepitant | Other / unclassified | 6.1 mg | — |
| Subject | Aprepitant | Other / unclassified | 10.3 mg | — |
| Comparator | Bupivacaine | Other / unclassified | 21.7 mg | — |
| Comparator | Bupivacaine | Other / unclassified | 30.6 mg | — |
| Comparator | Bupivacaine | Other / unclassified | 50 mg | — |
| Comparator | Bupivacaine | Other / unclassified | 51.5 mg | — |
| Subject | Meloxicam | Small molecule | 0.6 mg | — |
| Subject | Meloxicam | Small molecule | 0.9 mg | — |
| Subject | Meloxicam | Small molecule | 1.5 mg | — |
Indications
No indication recorded.