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Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

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ClinicalTrials.gov Identifier: NCT01433328
Recruitment Status : Terminated (Safety considerations)
First Posted : September 13, 2011
Last Update Posted : April 5, 2012
Sponsor:
Information provided by (Responsible Party):
Dr David Langleben, Jewish General Hospital

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Lidocaine Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain
Study Start Date : January 2012
Actual Primary Completion Date : March 2012
Actual Study Completion Date : April 2012


Arm Intervention/treatment
Experimental: Lidocaine Drug: Lidocaine
Lidocaine

Placebo Comparator: Placebo
Remodulin only
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Pain Questionnaire [ Time Frame: 1 week ]
    Short Form McGill Pain Questionnaire - Change from baseline over one week

  2. Daily Pain Diary [ Time Frame: 1 week ]
    10cm visual analogue scale (VAS) - Change in aggregated median/maximum scores over one week


Secondary Outcome Measures :
  1. proNT-BNP [ Time Frame: 1 week ]
  2. 6 minute walk [ Time Frame: 1 week ]
  3. Lidocaine level [ Time Frame: 1 week ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: April 5, 2012
Last Verified: April 2012

Keywords provided by Dr David Langleben, Jewish General Hospital:
Remodulin
Treprostinil

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Lidocaine
Treprostinil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents