Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Lidocaine

Placebo

Remodulin only

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Lidocaine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No