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Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Jewish General Hospital.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Dr David Langleben, Jewish General Hospital Identifier:
First received: June 6, 2012
Last updated: June 11, 2012
Last verified: June 2012
The investigators will test whether hypotonic (diluted) remodulin solution causes less pain than the eutonic (undiluted) solution supplied by the manufacturer.

Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: HypotonicTreprostinil Solution
Drug: Eutonic Treprostinil Solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Resource links provided by NLM:

Further study details as provided by Jewish General Hospital:

Primary Outcome Measures:
  • Daily Pain Diary [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • McGill Pain Questionnaire [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • CAMPHOR quality of life questionnaire [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • 6 minute walk distance [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • NT-proBNP level [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Arms Assigned Interventions
Experimental: Hypotonic Treprostinil Solution
Hypotonic Treprostinil Solution
Drug: HypotonicTreprostinil Solution
Hypotonic Treprostinil Solution
Other Name: Hypotonic Remodulin Solution
Active Comparator: Eutonic Treprostinil Solution
Eutonic Treprostinil Solution
Drug: Eutonic Treprostinil Solution
Eutonic Treprostinil Solution
Other Name: Eutonic Remodulin Solution


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01615627

Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Jewish General Hospital
Study Chair: David Langleben, MD Jewish General Hospital
  More Information

Responsible Party: Dr David Langleben, Chair, Cardiology Department, Jewish General Hospital Identifier: NCT01615627     History of Changes
Other Study ID Numbers: JGH-12-058 
Study First Received: June 6, 2012
Last Updated: June 11, 2012
Health Authority: Canada: Health Canada

Keywords provided by Jewish General Hospital:
Subcutaneous Treprostinil

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Pharmaceutical Solutions
Antihypertensive Agents processed this record on January 17, 2017