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Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

This study has been terminated.
(Safety considerations)
Sponsor:
Information provided by (Responsible Party):
Dr David Langleben, Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01433328
First received: September 9, 2011
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pulmonary Arterial Hypertension
 Drug: Lidocaine
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jewish General Hospital:

Primary Outcome Measures:
  • Pain Questionnaire [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Short Form McGill Pain Questionnaire - Change from baseline over one week

  • Daily Pain Diary [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    10cm visual analogue scale (VAS) - Change in aggregated median/maximum scores over one week


Secondary Outcome Measures:
  • proNT-BNP [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • 6 minute walk [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Lidocaine level [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: January 2012
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine Drug: Lidocaine
Lidocaine
Placebo Comparator: Placebo
Remodulin only
 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433328

Locations
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Jewish General Hospital
Investigators
Principal Investigator: David Langleben, MD Chair, Cardiology Department
  More Information

No publications provided

Responsible Party: Dr David Langleben, Chair, Cardiology Department, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01433328     History of Changes
Other Study ID Numbers: JGH-11-096
Study First Received: September 9, 2011
Last Updated: April 4, 2012
Health Authority: Canada: Health Canada

Keywords provided by Jewish General Hospital:
Remodulin
Treprostinil

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Lidocaine
Treprostinil
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 19, 2013