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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of Rochester.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
United Therapeutics
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT01260454
First received: December 9, 2010
Last updated: December 13, 2010
Last verified: November 2010
History of Changes
  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: Allocation: Non-Randomized
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:

U.S. FDA Resources

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 sum of those 14 maximum intensity pain scores (an "area under the curve" for 14 days after a site change).



Secondary Outcome Measures:
  • Pain associated with Qutenza patch application [ 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.

  • Use of narcotics following a treprostinil infusion site change [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    We will assess the use of narcotics which patients ordinarily require following a treprostinil infusion site change. Each patient will serve as their own control because we have prospectively collected data from each patient regarding several months worth of previous site changes (without Qutenza) before they enrolled in this current trial.


Estimated Enrollment: 10
Study Start Date: November 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Qutenza patch
We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.
 Drug: Qutenza (8% capsaicin)
We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes
Other Names:
  • Qutenza
  • Capsaicin

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260454

Contacts
Contact: Antonia Heininger 585-486-0960 ext 136 Antonia_Heininger@urmc.rochester.edu

Locations
United States, New York
Mary M. Parkes Asthma Center, University of Rochester Recruiting
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

No publications provided

Responsible Party: R James White, University of Rochester
ClinicalTrials.gov Identifier: NCT01260454     History of Changes
Other Study ID Numbers: Qutenza White
Study First Received: December 9, 2010
Last Updated: December 13, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Qutenza
Capsaicin
Remodulin
Treprostinil

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

ClinicalTrials.gov processed this record on May 16, 2013