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Lidocaine 5% patch for Low Back Pain

Phase 4

Waitlist Available

Research Sponsored by Cook County Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week and 1 month

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

All Individual Drugs Already Approved

Pivotal Trial

Summary

This trial will test if adding lidocaine patches to standard treatments helps people with sudden low back pain who leave the Emergency Department. The patches release a numbing medicine to reduce pain. Some participants will get medicated patches, while others will get patches without medicine. Lidocaine patches have been studied for various pain conditions, including postherpetic neuralgia, diabetic neuropathy, and low back pain, showing potential benefits in pain management.

Eligible Conditions

Low Back Pain
Lower Back Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week and 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week and 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Pain

Roland-Morris-24 back pain disability scale

Other study objectives

Repeat visits

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Lidocaine 5% patchExperimental Treatment2 Interventions

Patients will receive a 7 day supply (21 patches) of lidocaine 5% patches upon discharge from the emergency department in addition to "standard therapy" at the discretion of the treating emergency department physician.

Group II: Non-medicated patchActive Control2 Interventions

Patients will receive a 7 day supply (21 patches) of non-medicated patches upon discharge from the emergency department in addition to "standard therapy" at the discretion of the treating emergency department physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

standard therapy

2016

Completed Phase 3

~1200

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