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

Information source: University of Rochester
ClinicalTrials.gov processed this data on November 27, 2014
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 application

Use 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

Page last updated: November 27, 2014

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