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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

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

Phase: Phase 4

Status: Completed

Sponsored by: Astellas Pharma Inc

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

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 Details

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

Proportion of subjects using pain medications 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.

Eligibility

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

Locations and Contacts

Site 102, Antwerpen, Belgium

Site 103, Genk, Belgium

Site 101, Roeselare, Belgium

Site 202, Hradec Králové, Czech Republic

Site 203, Olomouc, Czech Republic

Site 201, Prague, Czech Republic

Site 302, Aalborg, Denmark

Site 301, Aarhus, Denmark

Site 402, Cork, Ireland

Site 403, Galway, Ireland

Site 404, Galway, Ireland

Site 401, Limerick, Ireland

Site 502, Hamar, Norway

Site 501, Skien, Norway

Site 603, Kosice, Slovakia

Site 602, Martin, Slovakia

Site 702, Glasgow, United Kingdom

Site 701, Liverpool, United Kingdom

Site 704, Manchester, United Kingdom

Site 703, Solihull, United Kingdom

Additional Information

Link to results on JAPIC

Starting date: July 2011
Last updated: March 4, 2013

Page last updated: August 23, 2015

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