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Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Primary Purpose

Pulmonary Arterial Hypertension

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Lidocaine
Placebo
Sponsored by
Jewish General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Remodulin, Treprostinil

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine

Placebo

Arm Description

Remodulin only

Outcomes

Primary Outcome Measures

Pain Questionnaire
Short Form McGill Pain Questionnaire - Change from baseline over one week
Daily Pain Diary
10cm visual analogue scale (VAS) - Change in aggregated median/maximum scores over one week

Secondary Outcome Measures

proNT-BNP
6 minute walk
Lidocaine level

Full Information

First Posted
September 9, 2011
Last Updated
January 30, 2023
Sponsor
Jewish General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01433328
Brief Title
Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain
Official Title
Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Safety considerations
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jewish General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Remodulin, Treprostinil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Remodulin only
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Lidocaine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Pain Questionnaire
Description
Short Form McGill Pain Questionnaire - Change from baseline over one week
Time Frame
1 week
Title
Daily Pain Diary
Description
10cm visual analogue scale (VAS) - Change in aggregated median/maximum scores over one week
Time Frame
1 week
Secondary Outcome Measure Information:
Title
proNT-BNP
Time Frame
1 week
Title
6 minute walk
Time Frame
1 week
Title
Lidocaine level
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Langleben, MD
Organizational Affiliation
Chair, Cardiology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

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Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

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