The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain
Recruitment status was Recruiting
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.
Pulmonary Arterial Hypertension
Drug: Qutenza (8% capsaicin)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Qutenza® Patch for Disabling Treprostinil Infusion Site Pain|
- Pain score on a visual analogue scale [ Time Frame: 14 days after a new infusion site ] [ Designated as safety issue: No ]
Patients will record the maximum intensity of pain (0-10) each day after placing an infusion site in a diary with which they are already comfortable. They will record the score each day for 14 days unless they have recorded "0" for two consecutive days.
The primary outcome measure will be the sum of those 14 maximum intensity pain scores (an "area under the curve" for 14 days after a site change).
- Pain associated with Qutenza patch application [ Time Frame: 60 minute period of patch application and subsequent 3 days ] [ Designated as safety issue: Yes ]Qutenza has not previously been used in patients with normal, healthy skin. We will assess the reaction to capsaicin in these patients as compared to the patients with unhealthy skin (post-herpetic neuralgia) who were studied in the registration trials for Qutenza.
- Use of narcotics following a treprostinil infusion site change [ Time Frame: 14 days ] [ Designated as safety issue: No ]We will assess the use of narcotics which patients ordinarily require following a treprostinil infusion site change. Each patient will serve as their own control because we have prospectively collected data from each patient regarding several months worth of previous site changes (without Qutenza) before they enrolled in this current trial.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: Qutenza patch
We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.
Drug: Qutenza (8% capsaicin)
We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260454
|Contact: Antonia Heininger||585-486-0960 ext 136||Antonia_Heininger@urmc.rochester.edu|
|United States, New York|
|Mary M. Parkes Asthma Center, University of Rochester||Recruiting|
|Rochester, New York, United States, 14623|
|Principal Investigator:||R James White, MD, PhD||University of Rochester|