The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain
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|ClinicalTrials.gov Identifier: NCT01260454|
Recruitment Status : Completed
First Posted : December 15, 2010
Results First Posted : February 22, 2016
Last Update Posted : April 21, 2016
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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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Pulmonary Arterial Hypertension||Drug: Qutenza (8% capsaicin)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Qutenza® Patch for Disabling Treprostinil Infusion Site Pain|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||April 2012|
Experimental: Qutenza patch
All participants actively treated with Qutenza
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.
- 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).
- 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.
- 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.
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|Ages Eligible for Study:||15 Years to 80 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Uncontrolled hypertension
- Recent stroke or myocardial infarction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260454
|United States, New York|
|Mary M. Parkes Asthma Center, University of Rochester|
|Rochester, New York, United States, 14623|
|Principal Investigator:||R James White, MD, PhD||University of Rochester|
|Responsible Party:||R. James White, Professor, University of Rochester|
|Other Study ID Numbers:||
|First Posted:||December 15, 2010 Key Record Dates|
|Results First Posted:||February 22, 2016|
|Last Update Posted:||April 21, 2016|
|Last Verified:||March 2016|
Pulmonary Arterial Hypertension
Respiratory Tract Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs