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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pulmonary Hypertension
Pulmonary Arterial Hypertension
Intervention Drug: Qutenza (8% capsaicin)
Enrollment 6
Recruitment Details 26 participants who were previously recruited for a study called "SubQ works" were screened for this study.
Pre-assignment Details Of the 26 screened 10 had a pain score > or = 6 on two consecutive days. 6 of these 10 agreed to enroll.
Arm/Group Title Qutenza Patch
Hide Arm/Group Description

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

Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Qutenza Patch
Hide Arm/Group Description

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

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  66.7%
>=65 years
2
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
5
  83.3%
Male
1
  16.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
mean pain level   [1] 
Mean (Standard Deviation)
Unit of measure:  Visual Analogue Scale
Number Analyzed 6 participants
4.15  (0.85)
[1]
Measure Description: 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.
mean worst pain level   [1] 
Mean (Standard Deviation)
Unit of measure:  Visual Analogue Scale
Number Analyzed 6 participants
7.99  (1.83)
[1]
Measure Description: 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.
Pain Relief Experienced with as needed Analgesics   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 6 participants
1.66  (0.86)
[1]
Measure Description: 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)
1.Primary Outcome
Title Pain Score on a Visual Analogue Scale
Hide Description

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).

Time Frame 14 days after a new infusion site
Hide Outcome Measure Data
Hide Analysis Population Description
One subject did not meet the inclusion criteria and was excluded from the efficacy analysis.
Arm/Group Title Qutenza Patch
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Visual Analogue Scale
2.89  (0.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Qutenza Patch
Comments This is open-label, uncontrolled data; the comparison is made between each individual's baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score
Hide Description 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.
Time Frame 60 minute period of patch application and subsequent 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Qutenza Patch
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
3
3.Secondary Outcome
Title Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change
Hide Description We counted the number of participants who used any amount of narcotic during the 14 day diary period.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
One subject did not meet the inclusion criteria and was excluded from the efficacy analysis.
Arm/Group Title Qutenza Patch
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Qutenza Patch
Hide Arm/Group Description

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

All-Cause Mortality
Qutenza Patch
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Qutenza Patch
Affected / at Risk (%)
Total   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Qutenza Patch
Affected / at Risk (%)
Total   4/6 (66.67%) 
General disorders   
pain at the application site  3/6 (50.00%) 
Infections and infestations   
nasal congestion  1/6 (16.67%) 
sore throat  1/6 (16.67%) 
Nervous system disorders   
headache  1/6 (16.67%) 
Vascular disorders   
hypertension  1/6 (16.67%) 
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
Responsible Party: R. James White, University of Rochester
ClinicalTrials.gov Identifier: NCT01260454     History of Changes
Other Study ID Numbers: Qutenza White
First Submitted: December 9, 2010
First Posted: December 15, 2010
Results First Submitted: January 22, 2016
Results First Posted: February 22, 2016
Last Update Posted: April 21, 2016