We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01260454
Recruitment Status : Completed
First Posted : December 15, 2010
Results First Posted : February 22, 2016
Last Update Posted : April 21, 2016
Sponsor:
Collaborator:
United Therapeutics
Information provided by (Responsible Party):
R. James White, University of Rochester

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Pulmonary Arterial Hypertension Drug: Qutenza (8% capsaicin) Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
Other Names:
  • Qutenza
  • Capsaicin


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, New York
Mary M. Parkes Asthma Center, University of Rochester
Rochester, New York, United States, 14623
Sponsors and Collaborators
University of Rochester
United Therapeutics
Investigators
Layout table for investigator information
Principal Investigator: R James White, MD, PhD University of Rochester
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: R. James White, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01260454    
Other Study ID Numbers: Qutenza White
First Posted: December 15, 2010    Key Record Dates
Results First Posted: February 22, 2016
Last Update Posted: April 21, 2016
Last Verified: March 2016
Keywords provided by R. James White, University of Rochester:
Qutenza
Capsaicin
Remodulin
Treprostinil
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
 Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs