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NCT01260454 · ClinicalTrials.gov registry record · Phase 2
The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain
A Phase 2 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01260454 is a Phase 2 study that has completed, run by University of Rochester. The registered enrollment target is 6 participants.
The verdict
NCT01260454, a Phase 2 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study 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
- DRUG Qutenza (8% capsaicin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01260454
The ClinicalTrials.gov registry entry for NCT01260454 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Qutenza (8% capsaicin) is the first listed.
NCT01260454 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01260454 about?
NCT01260454 is a clinical study titled "The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain". 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 pla...
What is the current status of trial NCT01260454?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2010-11. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01260454?
The interventions under investigation include: Qutenza (8% capsaicin) (DRUG).
Who is sponsoring clinical trial NCT01260454?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
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