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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 Dr David Langleben, Jewish General Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01615627
First Posted: June 8, 2012
Last Update Posted: June 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr David Langleben, Jewish General Hospital
  Purpose
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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 Dr David Langleben, Jewish General Hospital:

Primary Outcome Measures:
  • Daily Pain Diary [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • McGill Pain Questionnaire [ Time Frame: 2 weeks ]
  • CAMPHOR quality of life questionnaire [ Time Frame: 2 weeks ]
  • 6 minute walk distance [ Time Frame: 2 weeks ]
  • NT-proBNP level [ Time Frame: 2 weeks ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615627


Contacts
Contact: David Langleben, MD 514 340 8222 ext 8283 david.langleben@mcgill.ca
Contact: Benjamin Fox, BM BS 514 340 8222 ext 6843 ben.fox@mcgill.ca

Locations
Canada, Quebec
Jewish General Hospital Not yet recruiting
Montreal, Quebec, Canada, H3T 1E2
Principal Investigator: David Langleben, MD         
Sponsors and Collaborators
Jewish General Hospital
Investigators
Study Chair: David Langleben, MD Jewish General Hospital
  More Information

Responsible Party: Dr David Langleben, Chair, Cardiology Department, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01615627     History of Changes
Other Study ID Numbers: JGH-12-058
First Submitted: June 6, 2012
First Posted: June 8, 2012
Last Update Posted: June 12, 2012
Last Verified: June 2012

Keywords provided by Dr David Langleben, Jewish General Hospital:
Subcutaneous Treprostinil

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Pharmaceutical Solutions
Treprostinil
Antihypertensive Agents