NCT01260454

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

The Qutenza® Patch for Disabling Treprostinil Infusion Site Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Hypertension
• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Qutenza (8% capsaicin)	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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-12-01
• Completion: 2012-04-01
• First posted: 2010-12-15
• Last updated: 2016-04-21
• Results posted: 2016-02-22

Locations

1 site across 1 country: United States