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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01416116
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 4
Start date July 6, 2011
Completion date April 25, 2012