Adverse EffectsPhase 4NCT00925353

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

A Phase 4 study testing 4% lidocaine gel in people with Adverse Effects, run by Mountain States Tumor and Medical Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 35 years and older, women only
Conditions the study is for: Adverse Effects
What is being tested?: 4% lidocaine gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: Jan 2010to Feb 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

35 years and older
intact skin on breasts and chest wall

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

St. Luke's Mountain States Tumor Institute
Boise, Idaho, 83712

Other trials in United States

About this study

Conditions: Adverse Effects
Being tested: 4% lidocaine gel
Keywords: lidocaine, pre-medication, mammography, pain, safety
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00925353
Study group	Role	What they receive
lidocaine gel	Experimental	Not described Receives: Drug: 4% lidocaine gel

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter.
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.
Measured: Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after

Secondary outcomes (3)

EKG Changes
The PR interval (msec), QRS duration (msec), and QTc interval (msec) were compared between the baseline and subsequent EKG using paired t-tests.
Measured: Prior to gel application and 3 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.
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.
Measured: Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after
Frequencies of Moderate, Severe, or Life-threatening Side Effects
Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements
Measured: Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Feb 2010

First posted22 Jun 2009 (estimated)
Study startJan 2010
Primary completionFeb 2010
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Adverse EffectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00925353
Sponsor's protocol ID: MSTMRI-002
Status last verified: Dec 2013
First submitted: 18 Jun 2009
Last updated: 23 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lambertz CK, Johnson CJ, Montgomery PG, Maxwell JR, Fry SJ. Toxicity of topical lidocaine applied to the breasts to reduce discomfort during screening mammography. J Anaesthesiol Clin Pharmacol. 2012 Apr;28(2):200-4. doi: 10.4103/0970-9185.94859.
PubMed 22557743

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts
ClinicalTrials.gov ID: NCT00925353
Acronym / sponsor ID: MSTMRI-002
Conditions: Adverse Effects
Keywords: lidocaine, pre-medication, mammography, pain, safety
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Mountain States Tumor and Medical Research InstituteUniversity, hospital or other
Study start: Jan 2010
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 22 Jun 2009 (estimated)
Results: Posted 23 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
lidocaine gel	Experimental	Drug: 4% lidocaine gel

Who may qualify

Ages: 35 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

35 years and older
intact skin on breasts and chest wall

Key exclusion criteria (14 listed)

sensitivity or allergy to lidocaine
liver or kidney dysfunction
pregnant
breast feeding
currently smoke or chew tobacco

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
4% lidocaine gelAlso: TOPICAINE1 ounce 4% lidocaine gel on skin of breasts and chest wall for 1 hour under occlusion, then removed with warm water	Drug	lidocaine gel

Primary outcome

Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter.
Time frame: Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after
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.

3 secondary outcomes

EKG Changes
Time frame: Prior to gel application and 3 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.
Time frame: Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after
Frequencies of Moderate, Severe, or Life-threatening Side Effects
Time frame: Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after

Results and safety

Results posted to the registry on 23 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lidocaine Gel	13	10

Primary outcome: Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter.

Time frame: Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after. Median (Full Range). Unit: nanograms/mililiter

Measure	Lidocaine Gel Group n = 10
lidocaine	NA (NA to 310)
MEGX	NA (NA to NA)

Lidocaine Gel Group: Actual lab results shown: 1, p <0.05, non-compartmental pharmacokinetic

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lidocaine Gel	0 of 10 (0%)	7 of 10 (70%)	Not reported

Limitations and caveats (from the sponsor): No placebo comparison group; limited sample size; healthy subjects; lack of variation in doses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22557743Lambertz CK, Johnson CJ, Montgomery PG, Maxwell JR, Fry SJ. Toxicity of topical lidocaine applied to the breasts to reduce discomfort during screening mammography. J Anaesthesiol Clin Pharmacol. 2012 Apr;28(2):200-4. doi: 10.4103/0970-9185.94859.

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Not yet recruitingPhase 2
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Not yet recruitingPhase 2
The CARDIOPROTECT Trial
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RecruitingPhase 4
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Active, not recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Colleen K Lambertz, MSN, FNP principal investigator

St. Luke's Mountain States Tumor Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 4% lidocaine gel in people with Adverse Effects, run by Mountain States Tumor and Medical Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter. (time frame: Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00925353, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2013.