The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain

Study Overview
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Brief Summary
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Subcutaneous treprostinil (Remodulin) is effective therapy for pulmonary arterial hypertension, a life threatening disease of the lung blood vessels. Unfortunately, treprostinil is irritating to the skin and many patients experience intense pain at the infusion site for the first 7-10 days after placing a new subcutaneous infusion site. Qutenza is an FDA approved formulation of 8% capsaicin that is approved for the treatment of post-herpetic neuralgia, a painful skin condition. The investigators hypothesize that pretreatment of an area of skin with Qutenza would decrease the pain associated with a new treprostinil infusion site. The investigators hope that Qutenza will decrease both the intensity of the pain and the duration of the pain after patients place a new treprostinil infusion site. In this initial study, the investigators will provide Qutenza in open-label, unblinded fashion and ask patients to rate their pain using a diary tool with which they are already comfortable.

Official Title
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The Qutenza® Patch for Disabling Treprostinil Infusion Site Pain

Conditions
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Pulmonary Hypertension, Pulmonary Arterial Hypertension

Intervention / Treatment
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* Drug: Qutenza (8% capsaicin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pulmonary Hypertension Using subcutaneous treprostinil Already participating as a subject in our prospective study of infusion site pain Has documented debilitating pain (6/10 or greater) in the study after a site change Exclusion Criteria: Uncontrolled hypertension Recent stroke or myocardial infarction

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qutenza patch<br>All participants actively treated with Qutenza | Drug: Qutenza (8% capsaicin)<br>* We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.<br>* Other names: Capsaicin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score on a Visual Analogue Scale | Patients will record the maximum intensity of pain (0-10) each day after placing an infusion site in a diary with which they are already comfortable. They will record the score each day for 14 days unless they have recorded 0 for two consecutive days. The primary outcome measure will be the average of those 14 maximum intensity pain scores (the sum of the maximum for each day divided by the number of days, generally 14; range 0-10). | 14 days after a new infusion site | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score | Qutenza has not previously been used in patients with normal, healthy skin. We will assess the reaction to capsaicin in these patients as compared to the patients with unhealthy skin (post-herpetic neuralgia) who were studied in the registration trials for Qutenza. Pain immediately following Qutenza application was measured on a 10 point visual analog score with the word 'none' above 0 and 'agonizing' above 10. | 60 minute period of patch application and subsequent 3 days | 
| Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change | We counted the number of participants who used any amount of narcotic during the 14 day diary period. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Qutenza, Capsaicin, Remodulin, Treprostinil