Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Phase 4

Withdrawn

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: HypotonicTreprostinil Solution; Drug: Eutonic Treprostinil Solution

• Registration Number: NCT01615627
• Lead Sponsor: Jewish General Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-06
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-08
• Study Start: 2012-07-01
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-29
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hypotonic Treprostinil Solution	HypotonicTreprostinil Solution	Hypotonic Treprostinil Solution
Eutonic Treprostinil Solution	Eutonic Treprostinil Solution	Eutonic Treprostinil Solution

Primary Outcome Measures

Name	Time	Method
Daily Pain Diary	2 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada