A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Single Injection Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia in Subjects Undergoing Total Knee Arthroplasty

Trial Profile

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Single Injection Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia in Subjects Undergoing Total Knee Arthroplasty

Completed
Phase of Trial: Phase II/III

Latest Information Update: 01 Jun 2016

At a glance

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

    • 02 Mar 2015 Pacira Pharmaceuticals has received a Complete Response Letter from the U.S. FDA following a review of its sNDA for the use of EXPAREL in nerve block to provide postsurgical analgesia, according to a media release.
    • 18 Apr 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 27 Feb 2014 Top-line phase III results reported in a Pacira Pharmaceuticals media release.
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