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NCT01615627 Clinical Trial

Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Pulmonary Arterial Hypertension Clinical Trial

Official title:
Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01615627
Other study ID # JGH-12-058
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date July 1, 2012
Est. completion date February 28, 2019

Study information
Verified date February 2020
Source Jewish General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 28, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• HypotonicTreprostinil Solution
Hypotonic Treprostinil Solution
• Eutonic Treprostinil Solution
Eutonic Treprostinil Solution

Locations
Country Name City State
Canada Jewish General Hospital Montreal Quebec

Sponsors (1)
Lead Sponsor Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Daily Pain Diary 2 weeks
Secondary McGill Pain Questionnaire 2 weeks
Secondary CAMPHOR quality of life questionnaire 2 weeks
Secondary 6 minute walk distance 2 weeks
Secondary NT-proBNP level 2 weeks
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