Comparison of Prescription Lidocaine Patch to Over the Counter Lidocaine Patch and Placebo for Back Pain and Arthritis
Overview
- Phase
- Not Applicable
- Intervention
- lidocaine 5% patch
- Conditions
- Back Pain
- Sponsor
- J.A.R. Laboratories
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Efficacy comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
- Last Updated
- 10 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
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
- •Pain on the area of the body not conducive to patch therapy (eg fingers, toes etc)
Arms & Interventions
Lidocaine5% v Lidocaine3.6%,Menthol1.25%
Daily patch Q12 followed by Q12 of no patch
Intervention: lidocaine 5% patch
Lidocaine5% v Lidocaine3.6%,Menthol1.25%
Daily patch Q12 followed by Q12 of no patch
Intervention: lidocaine 3.6%, menthol 1.25%
Lidocaine 3.6%, menthol 1.25% v placebo
Daily patch Q12 followed by Q12 of no patch
Intervention: lidocaine 3.6%, menthol 1.25%
Lidocaine 3.6%, menthol 1.25% v placebo
Daily patch Q12 followed by Q12 of no patch
Intervention: Placebo
Outcomes
Primary Outcomes
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
Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten
Secondary Outcomes
- Quality of life comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale(Day ten)
- Efficacy comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale(Day 10)
- Side effect comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale(Day 10)
- Side effect comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale(Day 10)