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.
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
- 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.