Trial Outcomes & Findings for Brain Imaging of Lidoderm for Chronic Back Pain (NCT NCT01515540)

NCT ID: NCT01515540

Last Updated: 2013-07-30

Results Overview

the primary hypothesis was that the lidoderm 5% patch was expected to decrease pain intensity post treatment greater than placebo patch. A lower value on the 0-100 scale is considered to represent less pain. Higher values represent more pain. Greater than 20%-30% decrease in pain is considered clinically meaningful.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 38 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2013-07-30

Participant Flow

38 patients were recruited for the brain imaging and treatment study. Data from 7 subjects was not analyzed due to failure to attend the repeat sessions for non specific reasons and data from 1 subject was excluded from analysis due to technical faults. Thus, data from a total of 30 subjects was included in the brain imaging analysis.

Participant milestones

Measure	Lidocaine 5% lidoderm patch	Control placebo patch
Overall Study STARTED	20	18
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain Imaging of Lidoderm for Chronic Back Pain

Baseline characteristics by cohort

Measure	Lidocaine n=20 Participants 5% lidoderm patch	Control n=18 Participants placebo patch	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	53 years STANDARD_DEVIATION 7.7 • n=5 Participants	49.73 years STANDARD_DEVIATION 10.27 • n=7 Participants	51.36 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	18 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: based on a literature search.

the primary hypothesis was that the lidoderm 5% patch was expected to decrease pain intensity post treatment greater than placebo patch.

A lower value on the 0-100 scale is considered to represent less pain. Higher values represent more pain. Greater than 20%-30% decrease in pain is considered clinically meaningful.

Outcome measures

Measure	Lidocaine n=15 Participants 5% lidoderm patch	Control n=15 Participants placebo patch
Pain Intensity on a Visual Analog Scale (VAS) The Scale Had Values From 0-100, Where 0 Represents "no Pain" and 100 Was the "Worst Pain Imaginable".	51.0 peak pain intensity Standard Deviation 7.6	51.6 peak pain intensity Standard Deviation 7.1

Adverse Events

Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Javeria Ali Hashmi

Northwestern University

Phone: 3125037991

Email: j-hashmi@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place