The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain
Completed · Phase 2
Conditions studied: Pulmonary Hypertension, Pulmonary Arterial Hypertension
In brief
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.
Key facts
- Study ID
- NCT01260454
- Run by
- University of Rochester
- People needed
- 6
- Starts
- 2010-11-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2016-04-21
Who can join
Age: 15 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Uncontrolled hypertension
- Recent stroke or myocardial infarction
Where it is running
- Mary M. Parkes Asthma Center, University of Rochester — Rochester, New York, United States
Full record on ClinicalTrials.gov
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