Comparison of Prescription Lidocaine Patch to Over the Counter Lidocaine Patch and Placebo for Back Pain and Arthritis

A comparison of transdermal patches for efficacy, side effects and quality of life for patients with back pain and arthritis. The three arms in the trial were; prescription strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.

Study Overview

• Status: Unknown
• Conditions: Arthritis; Back Pain
• Intervention / Treatment: Drug: lidocaine 5% patch; Drug: lidocaine 3.6%, menthol 1.25%; Drug: Placebo

Detailed Description

In this comparison of; lidocaine 5%, lidocaine/menthol 1.25% and placebo for patients with back pain and arthritis, subjects had to qualify by meeting various inclusion and exclusion criteria. Subjects signed an informed consent and were randomized in a double blinded fashion to one of the three arms. After randomization subjects completed a baseline questionnaire regarding how pain affects their lives. Then they began therapy with their blinded product. This same questionnaire was administered after the second day of therapy and after the final day on day 10. Responses at the day two and ten endpoints were compared to baseline to access the response of each arm.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Barrington, Illinois, United States, 60010
      • Recruiting
      • Advocate Good Sheppard Hospital
      • Contact: Eric Castro, MD; Phone Number: 773-771-4160; Email: jedc269@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of back pain
• Diagnosis of arthritis

Exclusion Criteria:

• Pregnancy or expected pregnancy in the next three months
• Allergic to any lidocaine, menthol and methylparaben
• No reliable access to the internet
• Baseline average pain intensity of 1,2,9 or 10 on a scale of 0-to 10.
• Pain on the area of the body not conducive to patch therapy (eg fingers, toes etc)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine5% v Lidocaine3.6%,Menthol1.25%; Daily patch Q12 followed by Q12 of no patch	Drug: lidocaine 5% patch; 10cmx 14 cm transdermal patch sealed in its own pouch; Other Names: Lidoderm; Drug: lidocaine 3.6%, menthol 1.25%; 10cmx 14 cm transdermal patch sealed in its own pouch; Other Names: LidoPatch
Placebo Comparator: Lidocaine 3.6%, menthol 1.25% v placebo; Daily patch Q12 followed by Q12 of no patch	Drug: lidocaine 3.6%, menthol 1.25%; 10cmx 14 cm transdermal patch sealed in its own pouch; Other Names: LidoPatch; Drug: Placebo; patch with no active manufactured to have the same look and feel as Lidoderm 10cmx 14 cm transdermal patch sealed in its own pouch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale	Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten	Day ten

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale	Statistical superiority sought for lidocaine 3.6%,menthol 1.25% compared to placebo. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten.	Day ten
Efficacy comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale	Statistical superiority sought for lidocaine 3.6%,menthol 1.25% compared to placebo. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten.	Day 10
Side effect comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale	Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten.	Day 10
Side effect comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale	Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten.	Day 10

Collaborators and Investigators

• Sponsor: J.A.R. Laboratories

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: April 18, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthritis; Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Dermatologic Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Antipruritics; Lidocaine; Menthol
• Other Study ID Numbers: 527-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Investigators plan to share the study results as a whole but no plans to share individual results.