Phase II, multi-centre, randomised, two-part pilot study (Part 1 open, uncontrolled; Part 2 double-blind, placebo controlled) to determine the efficacy, safety, tolerability and preliminary pharmacokinetics of PSD502 [lidocaine/prilocaine] in the management of pain from donor sites in burns subjects undergoing skin grafts.

Trial Profile

Phase II, multi-centre, randomised, two-part pilot study (Part 1 open, uncontrolled; Part 2 double-blind, placebo controlled) to determine the efficacy, safety, tolerability and preliminary pharmacokinetics of PSD502 [lidocaine/prilocaine] in the management of pain from donor sites in burns subjects undergoing skin grafts.

Discontinued
Phase of Trial: Phase II

Latest Information Update: 24 Feb 2017

At a glance

  • Drugs Lidocaine/prilocaine (Primary)
  • Indications Pain
  • Focus Therapeutic Use
  • Sponsors Plethora Solutions
  • Most Recent Events

    • 25 Jun 2014 According to EudraCT, planned number of patients changed from 38 to 45 and phase added as phase II.
    • 25 Jun 2014 Status changed from active, no longer recruiting to discontinued according to EudraCT.
    • 31 Oct 2005 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