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Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch | Clinical Trials | Clareo Health

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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

NCT01416116•Astellas Pharma Inc

View on ClinicalTrials.gov

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.

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

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

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 (20)

Site 102

Antwerp, Belgium

Site 103

Genk, Belgium

Site 101

Roeselare, Belgium

Site 202

Hradec Králové, Czechia

Site 203

Olomouc, Czechia

Site 201

Prague, Czechia

Site 302

Aalborg, Denmark

Site 301

Aarhus, Denmark

Site 402

Cork, Ireland

Site 403

Galway, Ireland

Key Dates

Start Date

July 6, 2011

Primary Completion Date

April 25, 2012

Completion Date

April 25, 2012

Last Updated

April 23, 2018

Enrollment

122

ACTUAL participants

Conditions

or Peripheral Nerve Injury (PNI)Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)

Interventions

QUTENZA

DRUG

Lidocaine

DRUG

Tramadol

DRUG