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
Results First Received: January 22, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pulmonary Hypertension
Pulmonary Arterial Hypertension
Intervention: Drug: Qutenza (8% capsaicin)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
26 participants who were previously recruited for a study called "SubQ works" were screened for this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 26 screened 10 had a pain score > or = 6 on two consecutive days. 6 of these 10 agreed to enroll.

Reporting Groups
  Description
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.

Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes


Participant Flow:   Overall Study
    Qutenza Patch  
STARTED     6  
COMPLETED     6  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes


Baseline Measures
    Qutenza Patch  
Number of Participants  
[units: participants]
  6  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     2  
Gender  
[units: participants]
 
Female     5  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     6  
mean pain level [1]
[units: Visual Analogue Scale]
Mean (Standard Deviation)
  4.15  (0.85)  
mean worst pain level [2]
[units: Visual Analogue Scale]
Mean (Standard Deviation)
  7.99  (1.83)  
Pain Relief Experienced with as needed Analgesics [3]
[units: units on a scale]
Mean (Standard Deviation)
  1.66  (0.86)  
[1] Average pain over the 14 day diary period; measured by visual analog score. Pain was measured on a 10 point visual analog score with the word 'none' at 0 and 'agonizing' at 10.
[2] Worst pain was defined as the highest pain experienced on any day over the 14 day diary period; measured by visual analog score. Pain was measured on a 10 point visual analog score with the word 'none' at 0 and 'agonizing' at 10.
[3] average pain relief perceived after using prescribed analgesics over the 14 day diary period; measured by non-continuous, qualitative word scale (0= no relief, 1= a little, 2=some, 3=a lot and 4= complete relief)



  Outcome Measures
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1.  Primary:   Pain Score on a Visual Analogue Scale   [ Time Frame: 14 days after a new infusion site ]

2.  Secondary:   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 ]

3.  Secondary:   Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change   [ Time Frame: 14 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: R. James White, MD, PhD
Organization: University of Rochester
phone: 585-486-0869
e-mail: jim_white@urmc.rochester.edu



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
Results First Received: January 22, 2016
Last Updated: March 22, 2016
Health Authority: United States: Food and Drug Administration