Trial Outcomes & Findings for The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts (NCT NCT00925353)

Results Overview

Plasma concentration of lidocaine and MEGX in nanograms/milliliter were measured prior to one-time application of 4% lidocaine gel on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography, and at 30 minutes, 60 minutes, and 2, 3, 4, 6, and 8 hours. Due to the high frequency of nondetectable values, pharmacokinetic parameters could not be estimated. Measurements at all time points were grouped together to select a median.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

13 participants

Primary outcome timeframe

Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after

Results posted on

2013-12-23

Participant Flow

Recruitment fliers were posted at St. Luke's health System's oncology, screening mammography, internal medicine, and family health clinics, in-patient hospitals, and Boise State University.

56 potential subjects responded to the fliers during the enrollment period. 31 did not meet study criteria. 13 enrolled. 3 did not meet the preliminary EKG or laboratory criteria and were withdrawn prior to gel application. 10 subjects completed the trial.

Participant milestones

Participant milestones
Measure	Lidocaine Gel 1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
Overall Study STARTED	13
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Lidocaine Gel 1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
Overall Study Failed preliminary EKG or lab criteria.	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine Gel n=13 Participants 1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	53.9 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after

Population: Plasma lidocaine and MEGX levels were measured prior to lidociane gel application, and at 30 min, 60, min, and 2, 3, 4, 6, and 8 hours after on 10 subjects (total of 80 lidocaine levels and 80 MEGX levels). Minimum level of detection for lidocaine and MEGX was 200 ng/mL.

Plasma concentration of lidocaine and MEGX in nanograms/milliliter were measured prior to one-time application of 4% lidocaine gel on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography, and at 30 minutes, 60 minutes, and 2, 3, 4, 6, and 8 hours. Due to the high frequency of nondetectable values, pharmacokinetic parameters could not be estimated. Measurements at all time points were grouped together to select a median.

Outcome measures

Outcome measures
Measure	Lidocaine Gel Group n=160 plasma concentration Plasma concentration of lidocaine and MEGX after one-time application of 1 oz. of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography.
Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter. MEGX	NA nanograms/mililiter Measured values were below the level of detection = 200 ng/ml
Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter. lidocaine	NA nanograms/mililiter Interval to 310.0 Measured values were below the level of detection = 200 ng/ml

SECONDARY outcome

Timeframe: Prior to gel application and 3 hours after

The PR interval (msec), QRS duration (msec), and QTc interval (msec) were compared between the baseline and subsequent EKG using paired t-tests.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after

Variation of heart rate (bpm), respiratory rate (respirations per minute, rpm), systolic blood pressure (mm Hg), and diastolic blood pressure (mm Hg) over time was assessed using generalized linear mixed models with time modeled as a fixed effect and study subject modeled as a random effect.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after

Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements

Outcome measures

Outcome data not reported

Adverse Events

Lidocaine Gel

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lidocaine Gel n=10 participants at risk 1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
Skin and subcutaneous tissue disorders Skin erythema	70.0% 7/10 • Number of events 7

Additional Information

Colleen K. Lambertz, MBA, MSN, FNP

St. Luke's Mountain States Tumor and Medical Research Institute

Phone: 208 463 6018

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place