A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the XaraColl Bupivacaine Implant (300 mg Bupivacaine Hydrochloride) After Open Laparotomy Hernioplasty

Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the XaraColl Bupivacaine Implant (300 mg Bupivacaine Hydrochloride) After Open Laparotomy Hernioplasty

Completed
Phase of Trial: Phase III

Latest Information Update: 20 May 2017

At a glance

  • Drugs Bupivacaine (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Acronyms MATRIX-1
  • Sponsors Innocoll
  • Most Recent Events

    • 20 May 2017 Results of pooled analysis of MATRIX-1 and MATRIX-2 studies presented at the 36th Annual Scientific Meeting of the American Pain Society.
    • 20 May 2017 Results of pooled analysis of MATRIX-1 and MATRIX-2 studies presented at the 36th Annual Scientific Meeting of the American Pain Society.
    • 29 Dec 2016 According to an Innocoll media release, the company has received a refusal to file letter from the U.S. FDA for XARACOLL, for the treatment of postsurgical pain. Upon preliminary review, the FDA determined that the application, which was submitted in October 2016, was not sufficiently complete to permit a substantive review. The company is planning to discuss with FDA for re-filing of the application.
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