drugset / Trial / NCT01260454

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

NCT01260454

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-11
Primary completion
2011-12
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Capsaicin Small molecule 8 % Topical