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| Name | Class |
|---|---|
| United Therapeutics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qutenza patch | Experimental | All participants actively treated with Qutenza |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qutenza (8% capsaicin) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 14 days after a new infusion site |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R James White, MD, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mary M. Parkes Asthma Center, University of Rochester | Rochester | New York | 14623 | United States |
Of the 26 screened 10 had a pain score > or = 6 on two consecutive days. 6 of these 10 agreed to enroll.
26 participants who were previously recruited for a study called "SubQ works" were screened for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | One subject did not meet the inclusion criteria and was excluded from the efficacy analysis. | Posted | Mean | Standard Deviation | Visual Analogue Scale | 14 days after a new infusion site |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain at the application site | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R. James White, MD, PhD | University of Rochester | 585-486-0869 | jim_white@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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|
| 60 minute period of patch application and subsequent 3 days |
| 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. | 14 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| mean pain level | 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 | Standard Deviation | Visual Analogue Scale |
|
| mean worst pain level | 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. | Mean | Standard Deviation | Visual Analogue Scale |
|
| Pain Relief Experienced with as needed Analgesics | 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) | Mean | Standard Deviation | units on a scale |
|
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|
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| 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. | Posted | Number | participants | 60 minute period of patch application and subsequent 3 days |
|
|
|
| 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. | One subject did not meet the inclusion criteria and was excluded from the efficacy analysis. | Posted | Number | participants | 14 days |
|
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|
| 0 |
| 6 |
| 4 |
| 6 |
| headache | Nervous system disorders |
|
| nasal congestion | Infections and infestations |
|
| sore throat | Infections and infestations |
|
| hypertension | Vascular disorders |
|
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| D002318 |
| Cardiovascular Diseases |
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |