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A Phase III Randomized, Double-Blind Placebo-Controlled, Multi-Center, Parallel-Group, Repeated-Dose Study of the Analgesic Efficacy & Safety of Intravenous Acetaminophen [paracetamol; Acetavance; Cadence Pharmaceuticals] Versus Placebo for the Treatment of Postoperative Pain After Abdominal Laparoscopic Surgery

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Trial Profile

A Phase III Randomized, Double-Blind Placebo-Controlled, Multi-Center, Parallel-Group, Repeated-Dose Study of the Analgesic Efficacy & Safety of Intravenous Acetaminophen [paracetamol; Acetavance; Cadence Pharmaceuticals] Versus Placebo for the Treatment of Postoperative Pain After Abdominal Laparoscopic Surgery

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jun 2015

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At a glance

  • Drugs Paracetamol (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Mallinckrodt Inc.

Most Recent Events

  • 02 Nov 2010 According to a Cadence Pharmaceuticals media release, the US FDA has approved OFIRMEV (IV parcetamol) for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.
  • 17 Dec 2008 Primary endpoint 'Sum of pain intensity difference' has been met.
  • 17 Dec 2008 Positive top-line results announced by Cadence Pharmaceuticals.

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