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

Phase 2

Completed

• Conditions: Pulmonary Hypertension; Pulmonary Arterial Hypertension
• Interventions: Drug: Qutenza (8% capsaicin)

• Registration Number: NCT01260454
• Lead Sponsor: University of Rochester

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-15
• Primary Completion: 2011-12
• Study Completion: 2012-04
• Results First Submitted: 2016-01-22
• Results First Submitted QC: 2016-01-22
• Results First Posted: 2016-02-22
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Qutenza patch	Qutenza (8% capsaicin)	All participants actively treated with Qutenza

Primary Outcome Measures

Name	Time	Method
Pain Score on a Visual Analogue Scale	14 days after a new infusion site	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 average of those 14 maximum intensity pain scores (the sum of the maximum for each day divided by the number of days, generally 14; range 0-10).

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score	60 minute period of patch application and subsequent 3 days	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.
Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change	14 days	We counted the number of participants who used any amount of narcotic during the 14 day diary period.

Trial Locations

Locations (1)

Mary M. Parkes Asthma Center, University of Rochester; 🇺🇸 Rochester, New York, United States