Phase 4 N=13 Treatment

The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts

Adverse Effects

Bottom Line

View on ClinicalTrials.gov: NCT00925353 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2013

Primary outcome: Primary: Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter. — NA; NA nanograms/mililiter — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: 4% lidocaine gel (Drug)
Age: Adult, Older Adult · 35+ yrs
Sex: Female
Sponsor: Mountain States Tumor and Medical Research Institute
Primary completion: Feb 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter.	NA; NA	<0.05 sig
SECONDARY EKG Changes	—	—
SECONDARY Variation of Heart Rate (Bpm), Respiratory Rate (Respirations Per Minute, Rpm), Systolic Blood Pressure (mm Hg), and Diastolic Blood Pressure (mm Hg) Over Time.	—	—
SECONDARY Frequencies of Moderate, Severe, or Life-threatening Side Effects	—	—

Summary

The purpose of this study is to test the hypothesis that one-time application of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for pre-medication to reduce discomfort during screening mammography does not result in adverse effects, electrocardiogram (EKG) changes, or systemically toxic plasma concentration of lidocaine or its principal metabolite, monoethylglycinexylidide (MEGX).

Eligibility Criteria

Inclusion Criteria

35 years and older
intact skin on breasts and chest wall

Exclusion Criteria

sensitivity or allergy to lidocaine
liver or kidney dysfunction
pregnant
breast feeding
currently smoke or chew tobacco
used lidocaine products within 48 hours of baseline lab, EKG, or gel application
exhibit neurological or cardiac signs or symptoms prior to gel application
are taking antiarrythmic medications, ciprofloxacin, erythromycin products, or oral contraceptives
history of Wolffe-Parkinson-White Syndrome (WPW) or congestive heart failure
heart rate below 60 or above 100 beats per minute
systolic blood pressure below 95 or above 180 mm Hg
PR interval greater 200 msec, QRS duration greater than 120 msec, QTc greater than 450 msec, or evidence of WPW on EKG
have an automatic implantable cardioverter defibrillator (AICD) or cardiac pacemaker
have had cancer, surgery, trauma, or myocardial infarction in the past 6 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00925353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.