NCT02749123

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: J.A.R. Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Back Pain
• Arthritis

Interventions

Type	Name	Description
DRUG	lidocaine 5% patch	10cmx 14 cm transdermal patch sealed in its own pouch
DRUG	lidocaine 3.6%, menthol 1.25%	10cmx 14 cm transdermal patch sealed in its own pouch
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

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-04-22
• Last updated: 2016-04-22

Locations

1 site across 1 country: United States