Phase 2
N=6
The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain
Pulmonary Hypertension · Pulmonary Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01260454 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Pain Score on a Visual Analogue Scale — 2.89 Visual Analogue Scale — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Qutenza (8% capsaicin) (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score on a Visual Analogue Scale |
2.89 | 0.03 sig |
| SECONDARY Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score |
3 | — |
| SECONDARY Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change |
4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01260454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.