A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease Followed by an Open-Label Extension Phase

Trial Profile

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease Followed by an Open-Label Extension Phase

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Aug 2015

At a glance

  • Drugs Collagenase clostridium histolyticum (Primary)
  • Indications Dupuytren's contracture
  • Focus Registrational; Therapeutic Use
  • Acronyms CORD-II
  • Sponsors Auxilium Pharmaceuticals; Endo Pharmaceuticals
  • Most Recent Events

    • 08 May 2014 According to a Biospecifics Technologies Corporation media release, the supplement biologics license application (sBLA) for potential label expansion of Xiaflex is under FDA review with a PDUFA date of October 20, 2014.
    • 21 Oct 2013 New trial record
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