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

• Status: Completed
• Trial end date: 2012-04-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Capsaicin; Lidocaine; Tramadol

Criteria

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