A Phase 3, Randomized, Double Blind, Saline Placebo and Active Controlled, Multicenter Study of HTX 011 Via Local Administration for Postoperative Analgesia and Decreased Opioid Use Following Unilateral Simple Bunionectomy

Trial Profile

A Phase 3, Randomized, Double Blind, Saline Placebo and Active Controlled, Multicenter Study of HTX 011 Via Local Administration for Postoperative Analgesia and Decreased Opioid Use Following Unilateral Simple Bunionectomy

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Jun 2018

At a glance

  • Drugs Bupivacaine/meloxicam (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Heron Therapeutics
  • Most Recent Events

    • 21 Jun 2018 According to the Heron Therapeutics media release, HTX-011 for postoperative pain management has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), based on the results from this and other study (700280379).
    • 19 Mar 2018 According to Heron Therapeutics Media Release,Status changed from active, no longer recruiting to completed.
    • 19 Mar 2018 Results published in the Heron Therapeutics Media Release
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