CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 13 enrolled
Drug / intervention
4% lidocaine geldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00925353
NCT00925353Phase 4Completed
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The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts

Mountain States Tumor and Medical Research Institute·interventional·Posted Jun 22, 2009·Updated Dec 23, 2013

In Brief

A Phase 4 clinical trial evaluating 4% lidocaine gel for Adverse Effects. Completed, enrolled 13 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdverse Effects
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2009
Enrollment StartJan 1, 2010
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.0 years ago

Interventions

4% lidocaine geldrug

1 ounce 4% lidocaine gel on skin of breasts and chest wall for 1 hour under occlusion, then removed with warm water