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

J

J.A.R. Laboratories

Status

Unknown

Conditions

Back Pain
Arthritis

Treatments

Drug: lidocaine 3.6%, menthol 1.25%
Drug: Placebo
Drug: lidocaine 5% patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT02749123
527-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

Lidocaine5% v Lidocaine3.6%,Menthol1.25%
Active Comparator group
Description:
Daily patch Q12 followed by Q12 of no patch
Treatment:
Drug: lidocaine 5% patch
Drug: lidocaine 3.6%, menthol 1.25%
Lidocaine 3.6%, menthol 1.25% v placebo
Placebo Comparator group
Description:
Daily patch Q12 followed by Q12 of no patch
Treatment:
Drug: Placebo
Drug: lidocaine 3.6%, menthol 1.25%

Trial contacts and locations

1

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Central trial contact

James J Ciullo, MBA; Eric Castro, MD

Data sourced from clinicaltrials.gov

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