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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: Completed Phase 2 study, sponsored by University of Rochester.
NCT01260454 is a Phase 2 study that has completed, run by University of Rochester. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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).
Interventions
- DRUG Qutenza (8% capsaicin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
What the finished NCT01260454 record still lists
NCT01260454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Qutenza (8% capsaicin) is the first listed.
NCT01260454 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01260454's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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