drugset / Trial / NCT03015532

Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia

NCT03015532

Phase 2 Completed 285 enrolled Heron Therapeutics
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

EvaluationDrugModalityDoseRoute
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.