Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-01

Study Completion Date

2019-02-28

Brief Summary

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

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hypotonic Treprostinil Solution

Group Type EXPERIMENTAL

HypotonicTreprostinil Solution

Intervention Type DRUG

Hypotonic Treprostinil Solution

Eutonic Treprostinil Solution

Group Type ACTIVE_COMPARATOR

Eutonic Treprostinil Solution

Intervention Type DRUG

Eutonic Treprostinil Solution

Interventions

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HypotonicTreprostinil Solution

Hypotonic Treprostinil Solution

Intervention Type DRUG

Eutonic Treprostinil Solution

Intervention Type DRUG

Other Intervention Names

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Hypotonic Remodulin Solution Eutonic Remodulin Solution

Eligibility Criteria

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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)