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

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

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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%