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Completed

NCT Number: NCT01260454

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

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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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mary M. Parkes Asthma Center, University of Rochester

Rochester, New York, 14623, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qutenza (8% capsaicin)

Drug

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.

Other names: Qutenza, Capsaicin

Primary outcomes

  1. Pain Score on a Visual Analogue Scale

    Time frame: 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 outcomes

  1. Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score

    Time frame: 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.

  2. Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change

    Time frame: 14 days

    We counted the number of participants who used any amount of narcotic during the 14 day diary period.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • United Therapeutics

Registry information

Official study title

The Qutenza® Patch for Disabling Treprostinil Infusion Site Pain

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Dec 15, 2010
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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