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A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Intercostal Nerve Block with Liposome Bupivacaine in Subjects Undergoing Posterolateral Thoracotomy

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Intercostal Nerve Block with Liposome Bupivacaine in Subjects Undergoing Posterolateral Thoracotomy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jul 2021

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At a glance

  • Drugs Bupivacaine (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 30 Apr 2015 According to a Pacira Pharmaceuticals media release, the company has received a complete response letter from the US FDA following a review of its sNDA.
    • 01 Aug 2013 Complete data are expected in the next few weeks. Analyses are being conducted to elucidate why patients in some countries had positive results while those in other countries had high placebo responses, according to a Pacira Pharmaceuticals media release.
    • 01 Aug 2013 Top-line results published in a Pacira Pharmaceuticals media release.

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