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

September 9, 2011
April 4, 2012
January 2012
March 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01433328 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain
Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: Lidocaine
    Lidocaine
  • Drug: Placebo
    Placebo
  • Experimental: Lidocaine
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Placebo
    Remodulin only
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
April 2012
March 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01433328
JGH-11-096
No
Dr David Langleben, Jewish General Hospital
Jewish General Hospital
Not Provided
Principal Investigator: David Langleben, MD Chair, Cardiology Department
Jewish General Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP