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

This study has been completed.
Sponsor:
Collaborator:
United Therapeutics
Information provided by (Responsible Party):
R. James White, University of Rochester
ClinicalTrials.gov Identifier:
NCT01260454
First received: December 9, 2010
Last updated: March 22, 2016
Last verified: March 2016
  Purpose

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 Intervention Phase
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Drug: Qutenza (8% capsaicin)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Qutenza® Patch for Disabling Treprostinil Infusion Site Pain

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Pain Score on a Visual Analogue Scale [ Time Frame: 14 days after a new infusion site ] [ Designated as safety issue: No ]

    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:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    We counted the number of participants who used any amount of narcotic during the 14 day diary period.


Enrollment: 6
Study Start Date: November 2010
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260454

Locations
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
Principal Investigator: R James White, MD, PhD University of Rochester
  More Information

Responsible Party: R. James White, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01260454     History of Changes
Other Study ID Numbers: Qutenza White 
Study First Received: December 9, 2010
Results First Received: January 22, 2016
Last Updated: March 22, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Qutenza
Capsaicin
Remodulin
Treprostinil

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Capsaicin
Treprostinil
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents

ClinicalTrials.gov processed this record on September 28, 2016