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Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Primary Purpose

Pulmonary Arterial Hypertension

Status

Withdrawn

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

HypotonicTreprostinil Solution

Eutonic Treprostinil Solution

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Subcutaneous Treprostinil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypotonic Treprostinil Solution

Eutonic Treprostinil Solution

Arm Description

Hypotonic Treprostinil Solution

Eutonic Treprostinil Solution

Outcomes

Primary Outcome Measures

Daily Pain Diary

Secondary Outcome Measures

McGill Pain Questionnaire

CAMPHOR quality of life questionnaire

6 minute walk distance

NT-proBNP level

Full Information

NCT ID

NCT01615627

First Posted

June 6, 2012

Last Updated

February 29, 2020

Sponsor

Jewish General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01615627

Brief Title

Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Official Title

Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Withdrawn

Why Stopped

No enrollment

Study Start Date

July 1, 2012 (Actual)

Primary Completion Date

February 28, 2019 (Actual)

Study Completion Date

February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jewish General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Arterial Hypertension

Keywords

Subcutaneous Treprostinil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hypotonic Treprostinil Solution

Arm Type

Experimental

Arm Description

Hypotonic Treprostinil Solution

Arm Title

Eutonic Treprostinil Solution

Arm Type

Active Comparator

Arm Description

Eutonic Treprostinil Solution

Intervention Type

Drug

Intervention Name(s)

HypotonicTreprostinil Solution

Other Intervention Name(s)

Hypotonic Remodulin Solution

Intervention Description

Hypotonic Treprostinil Solution

Intervention Type

Drug

Intervention Name(s)

Eutonic Treprostinil Solution

Other Intervention Name(s)

Eutonic Remodulin Solution

Intervention Description

Eutonic Treprostinil Solution

Primary Outcome Measure Information:

Title

Daily Pain Diary

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

McGill Pain Questionnaire

Time Frame

2 weeks

Title

CAMPHOR quality of life questionnaire

Time Frame

2 weeks

Title

6 minute walk distance

Time Frame

2 weeks

Title

NT-proBNP level

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Langleben, MD

Organizational Affiliation

Jewish General Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Jewish General Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

12. IPD Sharing Statement

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Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

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