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

Astellas Pharma Inc122 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

122

Conditions

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

Interventions

QUTENZADRUG

topical

LidocaineDRUG

topical

TramadolDRUG

oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The proportion of subjects who tolerate QUTENZA treatment

A QUTENZA tolerant subject is defined as a subject receiving at least 90% of the intended patch duration.

Time frame: 60 minute application period

Secondary Outcomes

Duration of patch application

Time frame: 60 minutes

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

Time frame: 5, 25, 55, 85, 115 minutes on day of application and once a day on days 1, 2, 3

Proportion of subjects using pain medications and dose of pain medication(s) administered

Time frame: day 1-5

Subject rated tolerability score

Time frame: Baseline to end of study visit, day 7

Data from ClinicalTrials.gov

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