Trial | NCT02749123  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    lidocaine menthol ...

  • Study Participants

    100
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.
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.
Study Started
Apr 30
2016
Primary Completion
May 31
2016
Anticipated
Study Completion
May 31
2016
Anticipated
Last Update
Apr 22
2016
Estimate

Drug lidocaine 5% patch

10cmx 14 cm transdermal patch sealed in its own pouch

  • Other names: Lidoderm

Drug lidocaine 3.6%, menthol 1.25%

10cmx 14 cm transdermal patch sealed in its own pouch

  • Other names: LidoPatch

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

Lidocaine5% v Lidocaine3.6%,Menthol1.25% Active Comparator

Daily patch Q12 followed by Q12 of no patch

Lidocaine 3.6%, menthol 1.25% v placebo Placebo Comparator

Daily patch Q12 followed by Q12 of no patch

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 10.
Pain on the area of the body not conducive to patch therapy (eg fingers, toes etc)
No Results Posted