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Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

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ClinicalTrials.gov Identifier: NCT01615627
Recruitment Status : Unknown
Verified June 2012 by Dr David Langleben, Jewish General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 8, 2012
Last Update Posted : June 12, 2012
Sponsor:
Information provided by (Responsible Party):
Dr David Langleben, Jewish General Hospital

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

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: HypotonicTreprostinil Solution Drug: Eutonic Treprostinil Solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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


Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. McGill Pain Questionnaire [ Time Frame: 2 weeks ]
  2. CAMPHOR quality of life questionnaire [ Time Frame: 2 weeks ]
  3. 6 minute walk distance [ Time Frame: 2 weeks ]
  4. NT-proBNP level [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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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
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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
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Study Chair: David Langleben, MD Jewish General Hospital

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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 Posted: June 8, 2012    Key Record Dates
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:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Treprostinil
Pharmaceutical Solutions
Antihypertensive Agents