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Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

This study is not yet open for participant recruitment.
Verified June 2012 by Jewish General Hospital
Sponsor:
Information provided by (Responsible Party):
Dr David Langleben, Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01615627
First received: June 6, 2012
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  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
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
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:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
 Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013