Recruiting

Lidocaine Patch

Sponsor:

J.A.R. Laboratories

Code:

NCT02749123

Conditions

Back Pain

Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

lidocaine 5% patch

lidocaine 3.6%, menthol 1.25%

Placebo

Study Details

Brief summary:

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.

Conditions

Back Pain

Arthritis

Study ID

NCT02749123

Start date

Apr, 2016

Status verified date

Apr, 2016

Completion date

May, 2016

Anticipated

Primary completion date

May, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Lidocaine5% v Lidocaine3.6%,Menthol1.25%

Daily patch Q12 followed by Q12 of no patch

placebo comparator: Lidocaine 3.6%, menthol 1.25% v placebo

Daily patch Q12 followed by Q12 of no patch

Interventions

lidocaine 5% patch

10cmx 14 cm transdermal patch sealed in its own pouch

lidocaine 3.6%, menthol 1.25%

10cmx 14 cm transdermal patch sealed in its own pouch

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

Primary outcome measure

  • Efficacy comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale [ Time Frame: Day ten ]

Central Contacts and Locations

Central contacts

James J Ciullo, MBA

6302512873jay@lidopatch.com

Eric Castro, MD

773-771-4160jedc269@yahoo.com

Locations

Advocate Good Sheppard Hospital

Recruiting

Barrington, Illinois, United States, 60010

Contacts

Eric Castro, MD

773-771-4160jedc269@yahoo.com

More Information

Sponsor

J.A.R. Laboratories

Last update posted

Apr 22, 2016

Last verified

Apr, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by J.A.R. Laboratories on 2016-04-22.