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NCT01433328 Clinical Trial

Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01433328
Other study ID # JGH-11-096
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date January 2012
Est. completion date April 2012

Study information
Verified date January 2023
Source Jewish General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Treprostinil subcutaneous (under the skin) infusion is a very good medication for treating pulmonary arterial hypertension but infusion site pain may be very severe in some patients. The investigators plan to treat patients receiving treprostinil with a subcutaneous infusion of lidocaine (a local anesthestic) to treat the pain.

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date April 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - PAH - Treprostinil treatment for at least 3 months - Severe infusion site pain Exclusion Criteria: - Pregnancy/breastfeeding - Decompensated heart failure - Chronic liver disease - Abnormal electrolytes - Heart block (2/3 degree), sino-atrial block, idioventricular rhythm - Systolic systemic BP <90mmHg - Bradycardia HR <55 - Adverse reaction to lidocaine or other amide local anesthestic - Interacting medications (anti-arrhythmics, CYP1A2 inhibitors)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lidocaine
Lidocaine
• Placebo
Placebo

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 Pain Questionnaire Short Form McGill Pain Questionnaire - Change from baseline over one week 1 week
Primary Daily Pain Diary 10cm visual analogue scale (VAS) - Change in aggregated median/maximum scores over one week 1 week
Secondary proNT-BNP 1 week
Secondary 6 minute walk 1 week
Secondary Lidocaine level 1 week
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