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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: QUTENZA
* Drug: Lidocaine
* Drug: Tramadol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tramadol<br>Tramadol prior to QUTENZA | Drug: QUTENZA<br>* topical<br>* Other names: capsaicin 8% patch;Drug: Tramadol<br>* oral<br>|
| Experimental: Lidocaine<br>Lidocaine prior to QUTENZA | Drug: QUTENZA<br>* topical<br>* Other names: capsaicin 8% patch;Drug: Lidocaine<br>* topical<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 60 minute application period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of patch application |  | 60 minutes | 
| Change in pain scores from baseline to subsequent timepoints on the day of patch application |  | 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 |  | day 1-5 | 
| Subject rated tolerability score |  | Baseline to end of study visit, day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tramadol, QUTENZA, Pre-treatment, Tolerability