Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01615627

Enrollment

Registered

2012-06-08

Start date

2012-07-01

Completion date

2019-02-28

Last updated

2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Keywords

Subcutaneous Treprostinil

Brief summary

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

Interventions

DRUGHypotonicTreprostinil Solution

Hypotonic Treprostinil Solution

DRUGEutonic Treprostinil Solution

Eutonic Treprostinil Solution

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Daily Pain Diary	2 weeks

Secondary

Measure	Time frame
McGill Pain Questionnaire	2 weeks
CAMPHOR quality of life questionnaire	2 weeks
6 minute walk distance	2 weeks
NT-proBNP level	2 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026