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

Pulmonary Hypertension Clinical Trial

Official title:

The Qutenza® Patch for Disabling Treprostinil Infusion Site Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260454
• Other study ID #: Qutenza White
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2010
• Last updated: January 22, 2016
• Start date: November 2010
• Est. completion date: April 2012

Study information

• Verified date: January 2016
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Pulmonary Hypertension

Intervention

Drug:
• Qutenza (8% capsaicin)
We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.

Locations

Country	Name	City	State
United States	Mary M. Parkes Asthma Center, University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	United Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score on a Visual Analogue Scale	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).	14 days after a new infusion site	No
Secondary	Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score	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. Pain immediately following Qutenza application was measured on a 10 point visual analog score with the word 'none' above 0 and 'agonizing' above 10.	60 minute period of patch application and subsequent 3 days	Yes
Secondary	Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change	We counted the number of participants who used any amount of narcotic during the 14 day diary period.	14 days	No