The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain
Information source: University of Rochester
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Hypertension; Pulmonary Arterial Hypertension
Intervention: Qutenza (8% capsaicin) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Rochester Official(s) and/or principal investigator(s): R James White, MD, PhD, Principal Investigator, Affiliation: University of Rochester
Overall contact: Antonia Heininger, Phone: 585-486-0960, Ext: 136, Email: Antonia_Heininger@urmc.rochester.edu
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.
Clinical Details
Official title: The Qutenzaź Patch for Disabling Treprostinil Infusion Site Pain
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pain score on a visual analogue scale
Secondary outcome: Pain associated with Qutenza patch applicationUse of narcotics following a treprostinil infusion site change
Eligibility
Minimum age: 15 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Antonia Heininger, Phone: 585-486-0960, Ext: 136, Email: Antonia_Heininger@urmc.rochester.edu
Mary M. Parkes Asthma Center, University of Rochester, Rochester, New York 14623, United States; Recruiting
Additional Information
Starting date: November 2010
Last updated: December 13, 2010
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