NCT01615627

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
23 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

March 3, 2020

Status Verified

February 1, 2020

Enrollment Period

6.7 years

First QC Date

June 6, 2012

Last Update Submit

February 29, 2020

Conditions

Pulmonary Arterial Hypertension

Keywords

Subcutaneous Treprostinil

Outcome Measures

Primary Outcomes (1)

  • Daily Pain Diary

    2 weeks

Secondary Outcomes (4)

  • McGill Pain Questionnaire

    2 weeks

  • CAMPHOR quality of life questionnaire

    2 weeks

  • 6 minute walk distance

    2 weeks

  • NT-proBNP level

    2 weeks

Study Arms (2)

Hypotonic Treprostinil Solution

EXPERIMENTAL

Hypotonic Treprostinil Solution

Drug: HypotonicTreprostinil Solution

Eutonic Treprostinil Solution

ACTIVE COMPARATOR

Eutonic Treprostinil Solution

Drug: Eutonic Treprostinil Solution

Interventions

HypotonicTreprostinil SolutionDRUG

Hypotonic Treprostinil Solution

Also known as: Hypotonic Remodulin Solution
Hypotonic Treprostinil Solution
Eutonic Treprostinil SolutionDRUG

Eutonic Treprostinil Solution

Also known as: Eutonic Remodulin Solution
Eutonic Treprostinil Solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Known pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • David Langleben, MD

    Jewish General Hospital

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Cardiology Department

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 8, 2012

Study Start

July 1, 2012

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

March 3, 2020

Record last verified: 2020-02

Locations

CA(1)