Pulmonary Arterial Hypertension, Pulmonary Hypertension
Conditions
Keywords
Qutenza, Capsaicin, Remodulin, Treprostinil
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.
Interventions
DRUGQutenza (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.
Sponsors
United Therapeutics
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score on a Visual Analogue Scale | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score | 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 | 14 days | We counted the number of participants who used any amount of narcotic during the 14 day diary period. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Qutenza Patch |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| mean pain level | 4.15 Visual Analogue Scale STANDARD_DEVIATION 0.85 |
| mean worst pain level | 7.99 Visual Analogue Scale STANDARD_DEVIATION 1.83 |
| Pain Relief Experienced with as needed Analgesics | 1.66 units on a scale STANDARD_DEVIATION 0.86 |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Pain Score on a Visual Analogue Scale
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
Population: One subject did not meet the inclusion criteria and was excluded from the efficacy analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Qutenza Patch | Pain Score on a Visual Analogue Scale | 2.89 Visual Analogue Scale | Standard Deviation 0.71 |
Comparison: This is open-label, uncontrolled data; the comparison is made between each individual's baseline.p-value: 0.03t-test, 2 sided
Secondary
Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Qutenza Patch | Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score | 3 participants |
Secondary
Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change
We counted the number of participants who used any amount of narcotic during the 14 day diary period.
Time frame: 14 days
Population: One subject did not meet the inclusion criteria and was excluded from the efficacy analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Qutenza Patch | Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change | 4 participants |