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 Open Inguinal Herniorrhaphy

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 Open Inguinal Herniorrhaphy

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Jan 2018

At a glance

  • Drugs Bupivacaine/meloxicam (Primary) ; Bupivacaine
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Acronyms EPOCH 2
  • Sponsors Heron Therapeutics
  • Most Recent Events

    • 08 Jan 2018 According to a Heron Therapeutics media release, the company anticipates to file an NDA with the FDA in the second half of 2018.
    • 08 Jan 2018 Status changed from recruiting to active, no longer recruiting, as reported in a Heron Therapeutics media release.
    • 26 Oct 2017 Top-line results from this trial are expected in the first half of 2018, according to a Heron Therapeutics media release.
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