drugset / Trial / NCT03295721
Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
RandomizedParallel-groupTriple-blindPrevention
Summary
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing bunionectomy.
Timeline
- Start
- 2017-10-24
- Primary completion
- 2018-01-08
- Completion
- 2018-03-13
Publications
- Yip T, Hu J, Hawn PS, Yamamoto A, Oderda G. HTX-011 effectively reduces postoperative pain intensity and opioid use in the elderly. Pain Manag. 2022 Jan;12(1):45-57. doi: 10.2217/pmt-2021-0043. Epub 2021 Jul 21.
- Viscusi E, Gimbel JS, Pollack RA, Hu J, Lee GC. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study. Reg Anesth Pain Med. 2019 May 21:rapm-2019-100531. doi: 10.1136/rapm-2019-100531. Online ahead of print.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 50 mg | Other |
| Subject | Bupivacaine | Other / unclassified | 60 mg | Other |
| Subject | Meloxicam | Small molecule | 1.8 mg | Other |
Indications
No indication recorded.