drugset / Trial / NCT03015532
Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered via infiltration to the surgical site.
Timeline
- Start
- 2017-01-13
- Primary completion
- 2018-04-20
- Completion
- 2018-05-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 125 mg | Other |
| Subject | HTX-011 | Unknown | 200 mg | Other |
| Subject | HTX-011 | Unknown | 400 mg | Other |
| Subject | Ropivacaine | Other / unclassified | 50 mg | Other |
Indications
No indication recorded.