The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain
Status and phase
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
6 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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