Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01393795 | Qutenza®-Remodulin® in Pulmonary Arterial Hypertension Patients | PHASE2 | COMPLETED | 11 | — | — | Aug 1, 2011 | Jul 1, 2012 | Oct 5, 2023 | 1 | United Kingdom |
| NCT01260454 | The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain | PHASE2 | COMPLETED | 6 | — | — | Nov 1, 2010 | Apr 1, 2012 | Apr 21, 2016 | 1 | United States |
Safety evaluations will be based on the incidence, intensity and type of AEs and clinically significant changes in vital signs (pulse rate, blood pressure, respiration rate, pulse oximetry and temperature), and changes in concomitant medications throughout the study. Evaluation of safety will also be based on subject's physical examination, signs and symptoms of PAH, routine clinical laboratory tests (hematology, chemistry, coagulation panel, and urinalysis), ECG, and NYHA (WHO) classification at the screening and end of study follow up visits.
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).
| Arm | Type | Description |
|---|---|---|
| Tegaderm | PLACEBO_COMPARATOR | - |
| Qutenza | ACTIVE_COMPARATOR | - |
| Qutenza patch | EXPERIMENTAL | All participants actively treated with Qutenza |
| Name | Type | Description |
|---|---|---|
| Qutenza | DRUG | 8% patch |
| Tegaderm | DRUG | No active drug |
| 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. |
Inclusion Criteria: * 18 years or older with symptomatic PAH * Willing to provide written informed consent to participate in the study. * With documented diagnosis of PAH, either idiopathic, familial or associated with connective tissue disease, congenital heart disease or the use of anorexogenic d...