Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch

Tolerability of QUTENZATM When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study

The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is applied prior to the application of QUTENZA. This is a multi-center, randomized, assessor-blinded study which will investigate the use of an oral analgesic as an alternative form of pre-treatment for QUTENZA.

All patients will be treated with QUTENZA for 60 minutes. Patients will be randomized to one of two arms- application of topical anaesthetic (lidocaine cream) or an oral analgesic (tramadol oral tables) prior to application of QUTENZA. Patients will be followed up for 7 days to monitor pain scores and tolerability.

Inclusion Criteria:

• Diagnosis of postherpetic neuralgia or neuropathic pain due to peripheral nerve injury
• Daily pain score ≥ 4 for average pain both at the Screening Visit and at the Treatment Visit
• Intact, non-irritated, dry skin over the painful area(s) to be treated

Exclusion Criteria:

• Significant ongoing or recurrent pain other than due to PHN or peripheral nerve injury
• Past or current history of Type I or Type II diabetes mellitus
• Active malignancy or treatment for malignancy within a year prior to the Treatment Visit