LIFT

• Research type

  Research Study

• Full title

  Tolerability of QUTENZA(TM) when applied after pre-treatment with lidocaine or tramadol in subjects with peripheral neuropathic pain – A randomized, multi-center, assessor-blinded study

• IRAS ID

  76832

• Sponsor organisation

  Astellas Pharma Europe Ltd.

• Eudract number

  2010-023258-34

• Research summary

  This is a multi-center, randomized, assessor-blinded study which aims to investigate the tolerability of QUTENZA when applied after pre-treatment with either topical lidocaine or oral tramadol. This is a short-term study of a single application of a new topical patch treatment for patients with "peripheral neuropathic pain" or PNP for short. Patients with this condition to be treated can be those with postherpetic pain(something some people get following shingles)or those with nerve injuries following an operation or an accident resulting in PNP. The PNP treatment is a patch to be placed on the skin over the painful area. The patch contains a substance called capsaicin which is the chemical that makes chillies taste hot. Applying the patch can cause pain and discomfort. The reason for the study is to compare two different types of "pre-patch" pain killers to be used before the patch is applied to the skin. One is a local anaesthetic cream and the other in a pain-killer tablet. At the moment, the local anaesthetic is recommended but an oral medication would be much more convenient for doctors and patients. The study is being conducted in Europe and in four hospital sites in England and Scotland. Patients will receive one treatment with the patches and will be assessed as to how well they tolerate the treatment. The two groups of patients (local anaesthetic vs tablet pre-treatment)will be compared. The study will end about 7 days after treatment is applied. Treatment is applied in the hospital clinic by trained specialists and a visit for treatment and assessments of pain may last about 4 hours. All patients receive the active treatment - only the pre-patch pain-killer will differ. Patients can use a variety of pain treatments while the patch is on and after the patch has been removed if required.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0215

• Date of REC Opinion

  13 Jun 2011

• REC opinion

  Further Information Favourable Opinion