|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT01260454 |
|
Date of registration:
|
09/12/2010 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain
|
|
Scientific title:
|
The Qutenza® Patch for Disabling Treprostinil Infusion Site Pain |
|
Date of first enrolment:
|
November 2010 |
|
Target sample size:
|
6 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01260454 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
R James White, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Rochester |
| | |
|
Key inclusion & exclusion 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
Age minimum:
15 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Pulmonary Hypertension
|
|
Pulmonary Arterial Hypertension
|
|
Intervention(s)
|
|
Drug: Qutenza (8% capsaicin)
|
|
Primary Outcome(s)
|
|
Pain Score on a Visual Analogue Scale
[Time Frame: 14 days after a new infusion site]
|
|
Secondary Outcome(s)
|
|
Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change
[Time Frame: 14 days]
|
|
Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score
[Time Frame: 60 minute period of patch application and subsequent 3 days]
|
|
Secondary ID(s)
|
|
Qutenza White
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|