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A Phase 3, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety of Tramadol Infusion (AVE-901) in the Management of Post-Operative Pain Following Surgery

Trial Profile

A Phase 3, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety of Tramadol Infusion (AVE-901) in the Management of Post-Operative Pain Following Surgery

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Nov 2019

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At a glance

  • Drugs Tramadol (Primary)
  • Indications Postoperative pain
  • Focus Adverse reactions; Registrational
  • Sponsors Avenue Therapeutics
  • Most Recent Events

    • 04 Nov 2019 According to an Avenue Therapeutics media release, the company is on track to submit a New Drug Application for IV tramadol to the U.S. Food and Drug Administration by year-end 2019.
    • 07 May 2019 Status changed from recruiting to active, no longer recruiting.
    • 02 Jan 2018 According to an Avenue Therapeutics media release, the first patients have been dosed in this trial. The results of this trial will support a new drug application (NDA), which the company expects to submit to the US FDA in late 2019.
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