A clinical trial of GW856553 in patients with nerve injury pain

• Research type

  Research Study

• Full title

  A randomised, double blind study to evaluate the safety and efficacy of the p38 kinase inhibitor, GW856553, in subjects with neuropathic pain from peripheral nerve injury

• IRAS ID

  28660

• Contact name

  Praveen Anand

• Sponsor organisation

  GlaxoSmithKline, Clinical Pharmacology Science and Study Operations (CPSSO)

• Eudract number

  2009-010091-17

• ISRCTN Number

  Not Known

• Research summary

  Neuropathic pain is a diverse group of pain syndromes associated with nervous system injury. In humans, peripheral nerve injury (PNI) caused by trauma or surgery often leads to pain and sensitisation in the affected area. Several lines of evidence suggest a role for the enzyme p38 in controlling the level of nerve excitability, both in the periphery and in the CNS, under conditions of neuropathic pain. GW856553 is an inhibitor of p38a mitogen-activated protein kinase (MAPK) and is being developed for a variety of inflammatory conditions. This is a multi-centre double-blind, randomised, placebo-controlled, parallel group study. Subjects will undertake a screening period which may last up to approximately 3 weeks, followed by a baseline period of 1 week, a randomised treatment period of 4 weeks and a follow-up period of approximately 2 weeks. It will investigate the efficacy, safety and tolerability of GW856553 over 28 days of treatment in subjects who have at least moderate intensity of neuropathic pain resulting from peripheral nerve injury due to trauma or surgery. Randomisation ratio will be 1:1 for placebo or GW856553 respectively. The dose of GW856553 will be 7.5 mg BID. Subjects who are already on medications for the treatment of their neuropathic pain will be allowed to continue these medications provided they have been at a stable dose for at least 4 weeks before randomisation and provided they are not otherwise prohibited in the protocol. They will visit the clinic at screening, at the start of the baseline period (Week -1, Day -7), at randomisation (Day 1) and weekly during treatment for efficacy and safety assessment. A follow-up visit will take place approximately 2 weeks after the last dose of study medication. Efficacy endpoints will be evaluated at the follow-up visit to investigate the sustainability of any pain relief after stopping GW856553.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  09/H0706/68

• Date of REC Opinion

  22 Jan 2010

• REC opinion

  Further Information Favourable Opinion