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

Condition(s) targeted: Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN); Peripheral Nerve Injury

Intervention: QUTENZA (Drug); Lidocaine (Drug); Tramadol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Associate Director, Late Phase Clinical Development & Operations, Study Director, Affiliation: Astellas Pharma Europe BV

Overall contact:
Medical Affairs Europe, Phone: + 44 1784 419400, Email: contact@nl.astellas.com

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The proportion of subjects who tolerate QUTENZA treatment

Secondary outcome:

Duration of patch application

Change in pain scores from baseline to subsequent timepoints on the day of patch application

Total number and dose of pain medication(s) administered

Subject rated tolerability score

Detailed 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.

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

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

Medical Affairs Europe, Phone: + 44 1784 419400, Email: contact@nl.astellas.com

Site 102, Antwerpen, Belgium; Not yet recruiting

Site 103, Genk, Belgium; Recruiting

Site 101, Roeselare, Belgium; Not yet recruiting

Site 202, Hradec Králové, Czech Republic; Not yet recruiting

Site 203, Olomouc, Czech Republic; Not yet recruiting

Site 201, Prague, Czech Republic; Not yet recruiting

Site 302, Aalborg, Denmark; Not yet recruiting

Site 301, Aarhus, Denmark; Not yet recruiting

Site 402, Cork, Ireland; Not yet recruiting

Site 403, Galway, Ireland; Not yet recruiting

Site 404, Galway, Ireland; Not yet recruiting

Site 401, Limerick, Ireland; Not yet recruiting

Site 502, Hamar, Norway; Not yet recruiting

Site 501, Skien, Norway; Not yet recruiting

Site 601, Bystrica, Slovakia; Not yet recruiting

Site 603, Kosice, Slovakia; Recruiting

Site 602, Martin, Slovakia; Not yet recruiting

Site 702, Glasgow, United Kingdom; Not yet recruiting

Site 701, Liverpool, United Kingdom; Not yet recruiting

Site 704, Manchester, United Kingdom; Not yet recruiting

Site 703, Solihull, United Kingdom; Not yet recruiting

Starting date: July 2011
Last updated: August 11, 2011