drugset / Trial / NCT03237481
Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)
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 unilateral open inguinal herniorrhaphy.
Timeline
- Start
- 2017-07-31
- Primary completion
- 2017-12-22
- Completion
- 2018-01-16
Publications
- Minkowitz H, Soto R, Fanikos J, Hammer GB, Mehta N, Hu J, Redan J. Opioid-Free Recovery After Hernia Repair with HTX-011 as the Foundation of a Non-Opioid, Multimodal Analgesia Regimen in a Real-World Setting: A Randomized, Open-Label Study. Pain Ther. 2021 Dec;10(2):1295-1308. doi: 10.1007/s40122-021-00289-2. Epub 2021 Jul 27.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 75 mg | Other |
| Subject | HTX-011 | Unknown | 9 mg | Other |
| Subject | HTX-011 | Unknown | 300 mg | Other |
Indications
No indication recorded.