Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Jewish General Hospital

Overview

The investigators will test whether hypotonic (diluted) remodulin solution causes less pain than the eutonic (undiluted) solution supplied by the manufacturer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Pulmonary Arterial Hypertension

Interventions

HypotonicTreprostinil SolutionDRUG

Hypotonic Treprostinil Solution

Eutonic Treprostinil SolutionDRUG

Eutonic Treprostinil Solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * PAH by standard criteria * Treatment with subcutaneous remodulin infusion for at least 3 months, with stable dose for 1 month * Pain at infusion site (defined as \> 8 on McGill Pain Questionnaire) Exclusion Criteria: * Known pregnancy or breastfeeding

Locations (1)

Jewish General Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Daily Pain Diary

Time frame: 2 weeks

Secondary Outcomes

McGill Pain Questionnaire

Time frame: 2 weeks

CAMPHOR quality of life questionnaire

Time frame: 2 weeks

6 minute walk distance

Time frame: 2 weeks

NT-proBNP level

Time frame: 2 weeks

Data from ClinicalTrials.gov

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