A Randomized Double-Blind, Placebo- and Active-Controlled, Dose-Ranging Study to Evaluate the Analgesic, Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Open Abdominal Hysterectomy.

Trial Profile

A Randomized Double-Blind, Placebo- and Active-Controlled, Dose-Ranging Study to Evaluate the Analgesic, Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Open Abdominal Hysterectomy.

Completed
Phase of Trial: Phase II

Latest Information Update: 31 Jul 2017

At a glance

  • Drugs Meloxicam (Primary) ; Morphine
  • Indications Postoperative pain
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Alkermes plc
  • Most Recent Events

    • 31 Jul 2017 According to a company media release, lRecro Pharma has submitted an NDA to the US FDA for intravenous (IV) meloxicam 30mg for the treatment of moderate to severe, acute postoperative pain. The NDA is supported by positive results from two pivotal Phase III clinical efficacy trials in patients following bunionectomy and abdominoplasty surgeries, a large double-blind Phase III safety trial and four Phase II clinical trials for the management of moderate to severe postoperative pain.
    • 14 May 2016 Results presented at the 35th Annual Scientific Meeting of the American Pain Society
    • 12 May 2016 Results published at the American Pain Society's 35th Annual Scientific Meeting, as per Recro Pharma media release.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top