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A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.

Trial Profile

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Dec 2020

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At a glance

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

    • 18 Nov 2020 According to a Pacira BioSciences media release, based on four pivotal Phase 3 studies (402C326, 402C327, SKY0402C317, SKY0402C316), the European Commission has granted marketing authorization for EXPAREL as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults.
    • 19 Dec 2011 Results published in Diseases of the Colon & Rectum, according to a Pacira Pharmaceuticals media release.
    • 01 Dec 2011 Results published in Diseases of the Colon and Rectum.

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