Lidocaine Subcutaneous Infusion for Control of Treprostin... | NCT01433328

Studies
Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

NCT01433328

Sponsor

Jewish General Hospital

Status

Terminated

Last Update Posted

Feb 1, 2023Actual

Enrollment

4Actual

Phase

Phase 4

Conditions

Pulmonary Arterial Hypertension

Interventions

Lidocaine
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Safety considerations

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Mar 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Sep 9, 2011

First Submission Date that Met QC Criteria

Sep 12, 2011

First Posted Date

Sep 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2023

Last Update Posted Date

Feb 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lidocaine	Experimental		Drug: Lidocaine
Placebo	Placebo Comparator	Remodulin only	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine	Drug	Lidocaine	Lidocaine
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
proNT-BNP		1 week
6 minute walk		1 week
Lidocaine level

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Langleben, MD	Chair, Cardiology Department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jewish General Hospital		Montreal	Quebec	H3T 1E2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D000081029	Pulmonary Arterial Hypertension

Ancestor Terms

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided