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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

December 9, 2010
March 22, 2016
November 2010
December 2011   (final data collection date for primary outcome measure)
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).

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).

Complete list of historical versions of study NCT01260454 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain
The Qutenza® Patch for Disabling Treprostinil 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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pulmonary Hypertension
  • Pulmonary Arterial Hypertension
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
Experimental: Qutenza patch
All participants actively treated with Qutenza
Intervention: Drug: Qutenza (8% capsaicin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
April 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
15 Years to 80 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01260454
Qutenza White
No
Not Provided
Not Provided
R. James White, University of Rochester
University of Rochester
United Therapeutics
Principal Investigator: R James White, MD, PhD University of Rochester
University of Rochester
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP