View Clinical Trial (Medical Research Study)
The Qutenza® Patch for Disabling Treprostinil Infusion Site Pain
| City: |
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Rochester |
| State: |
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New York |
| Zip Code: |
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14623 |
| Conditions: |
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Pulmonary Hypertension - Pulmonary Arterial Hypertension |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01260454 |
| Primary Contact: |
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Principal Investigator
R James White, MD, PhD
University of Rochester
Antonia Heininger
Phone: 585-486-0960 ext. 136
Email: Antonia_Heininger@urmc.rochester.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Rochester, New York 14623
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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