A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Femoral Nerve Block With EXPAREL for Postsurgical Analgesia in Subjects Undergoing Total Knee Arthroplasty

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Femoral Nerve Block With EXPAREL for Postsurgical Analgesia in Subjects Undergoing Total Knee Arthroplasty

Recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2017

At a glance

  • Drugs Bupivacaine (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Pacira Pharmaceuticals
  • Most Recent Events

    • 02 Aug 2017 According to a Pacira Pharmaceuticals media release, the results of this and another phase III trial (see CT 269389) safety and pharmacokinetic data through 120 days, and data from other peripheral nerve block comparator studies will serve as the basis of an sNDA submission to the US FDA later this year, seeking expansion of the EXPAREL label to include administration via nerve block.
    • 28 Apr 2017 Planned End Date changed from 1 Feb 2017 to 1 Jul 2017.
    • 28 Apr 2017 Planned primary completion date changed from 1 Jan 2017 to 1 Jul 2017.
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