NCT01433328

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

September 9, 2011

Last Update Submit

January 30, 2023

Conditions

Pulmonary Arterial Hypertension

Keywords

RemodulinTreprostinil

Outcome Measures

Primary Outcomes (2)

  • Pain Questionnaire

    Short Form McGill Pain Questionnaire - Change from baseline over one week

    1 week

  • Daily Pain Diary

    10cm visual analogue scale (VAS) - Change in aggregated median/maximum scores over one week

    1 week

Secondary Outcomes (3)

  • proNT-BNP

    1 week

  • 6 minute walk

    1 week

  • Lidocaine level

    1 week

Study Arms (2)

Lidocaine

EXPERIMENTAL
Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

Remodulin only

Drug: Placebo

Interventions

LidocaineDRUG

Lidocaine

Lidocaine
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PAH
  • Treprostinil treatment for at least 3 months
  • Severe infusion site pain

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • David Langleben, MD

    Chair, Cardiology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Cardiology Department

Study Record Dates

First Submitted

September 9, 2011

First Posted

September 13, 2011

Study Start

January 1, 2012

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

February 1, 2023

Record last verified: 2023-01

Locations

CA(1)