The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain

NCT01260454 | Completed Phase 2 Results

• 1 other identifier: Qutenza White
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Hypertension; Pulmonary Arterial Hypertension

Keywords

Qutenza; Capsaicin; Remodulin; Treprostinil

Outcome Measures

Primary Outcomes (1)

• Pain Score on a Visual Analogue Scale

  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).

  14 days after a new infusion site

Secondary Outcomes (2)

• 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

Study Arms (1)

Qutenza patch

EXPERIMENTAL

All participants actively treated with Qutenza

Drug: Qutenza (8% capsaicin)

Interventions

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.

Also known as: Qutenza, Capsaicin

Qutenza patch

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncontrolled hypertension
• Recent stroke or myocardial infarction

Sponsors & Collaborators

• University of Rochester: lead
• United Therapeutics: collaborator

Study Sites (1)

Mary M. Parkes Asthma Center, University of Rochester

Rochester, New York, 14623, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: R. James White, MD, PhD
• Organization: University of Rochester

jim_white@urmc.rochester.edu

585-486-0869

Study Officials

• R James White, MD, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 15, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: April 21, 2016
• Results First Posted: February 22, 2016

Record last verified: 2016-03

Locations

US (1)