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Qutenza

Phase 2

Pulmonary Hypertension | Small molecule | Cardiovascular |United Therapeutics Corporation|Last Updated: Apr 21, 2016

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

Qutenza · 1 trial · 2 indications

Phase 2 1
NCT01260454The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site PainPulmonary Hypertension
COMPLETED6 Analytics
PHASE2COMPLETED
The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain
Pulmonary HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change
14 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Qutenza patchEXPERIMENTALAll participants actively treated with Qutenza

Interventions

NameTypeDescription
Qutenza (8% capsaicin)DRUGWe 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.
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Eligibility Criteria

Age Range15 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 ...

Countries:United States
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Frequently asked questions about Qutenza

What is Qutenza used for in pulmonary hypertension?

Qutenza is a small molecule being studied for the treatment of pulmonary hypertension and pulmonary arterial hypertension. It is delivered as a patch and is currently in Phase 2 clinical development for this indication. The drug is being developed by United Therapeutics Corporation.

How does Qutenza work?

Qutenza is a small molecule delivered via a patch. It is being investigated for its potential to treat pulmonary hypertension, a condition characterized by high blood pressure in the lungs. The specific molecular target of Qutenza has not been disclosed in the available information.

Who makes Qutenza?

Qutenza is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical research on Qutenza as a potential treatment for pulmonary hypertension.

What phase is Qutenza in for pulmonary hypertension?

Qutenza is in Phase 2 clinical development for pulmonary hypertension. A Phase 2 clinical trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities for this indication.

What clinical trials has Qutenza been in?

Qutenza has been studied in one completed Phase 2 clinical trial with the identifier NCT01260454. The trial, titled "The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain," enrolled 6 participants in the United States and included patients with pulmonary hypertension and pulmonary arterial hypertension.

Is Qutenza the same as a capsaicin patch?

Qutenza is a patch formulation of a small molecule. It is being investigated for use in pulmonary hypertension, specifically to address pain associated with treprostinil infusion. The active ingredient and any alternative names for Qutenza have not been specified in the available information.