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

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: United Therapeutics
• Treatments: Capsaicin; Treprostinil

Criteria

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