Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Jewish General Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Eutonic Treprostinil Solution; Drug: HypotonicTreprostinil Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01615627

JGH-12-058

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Hypotonic Treprostinil Solution

Experimental group

Description:

Hypotonic Treprostinil Solution

Treatment:

Drug: HypotonicTreprostinil Solution

Eutonic Treprostinil Solution

Active Comparator group

Description:

Eutonic Treprostinil Solution

Treatment:

Drug: Eutonic Treprostinil Solution