A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2017

At a glance

  • Drugs Sufentanil (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors AcelRx Pharmaceuticals
  • Most Recent Events

    • 01 Aug 2017 According to an AcelRx Pharmaceuticals media release, the company intends to submit results from IAP312 study together with results of phase 3 studies (IAP309, IAP310 and IAP311) as part of resubmission of a New Drug Application to the FDA by the end of 2017.
    • 22 Sep 2015 Results published in AcelRx media release.
    • 03 Aug 2015 AcelRx Pharmaceuticals has been granted a General Advice meeting with the U.S. FDA in early September to discuss the FDA's request for a clinical trial and the company's planned response to the Complete Response Letter issued by the FDA for the NDA for Zalviso.
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