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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
Sponsor:
Collaborator:
United Therapeutics
Information provided by (Responsible Party):
R. James White, University of Rochester

Tracking Information
First Submitted Date  ICMJE December 9, 2010
First Posted Date  ICMJE December 15, 2010
Results First Submitted Date  ICMJE January 22, 2016
Results First Posted Date  ICMJE February 22, 2016
Last Update Posted Date April 21, 2016
Study Start Date  ICMJE November 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 13, 2010)
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 sum of those 14 maximum intensity pain scores (an "area under the curve" for 14 days after a site change).
Change History Complete list of historical versions of study NCT01260454 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2010)
  • Pain associated with Qutenza patch application [ 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.
  • Use of narcotics following a treprostinil infusion site change [ Time Frame: 14 days ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain
Official Title  ICMJE The Qutenza® Patch for Disabling Treprostinil Infusion Site Pain
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Hypertension
  • Pulmonary Arterial Hypertension
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Qutenza patch
All participants actively treated with Qutenza
Intervention: Drug: Qutenza (8% capsaicin)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2016)
6
Original Estimated Enrollment  ICMJE
 (submitted: December 13, 2010)
10
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01260454
Other Study ID Numbers  ICMJE Qutenza White
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party R. James White, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE United Therapeutics
Investigators  ICMJE
Principal Investigator: R James White, MD, PhD University of Rochester
PRS Account University of Rochester
Verification Date March 2016

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