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

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ClinicalTrials.gov Identifier: NCT02749123
Recruitment Status : Unknown
Verified April 2016 by J.A.R. Laboratories.
Recruitment status was:  Recruiting
First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
J.A.R. Laboratories

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.

Condition or disease Intervention/treatment Phase
Back Pain Arthritis Drug: lidocaine 5% patch Drug: lidocaine 3.6%, menthol 1.25% Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Prescription Lidocaine Patch to Over the Counter Lidocaine Patch and Placebo for Back Pain and Arthritis
Study Start Date : April 2016
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine5% v Lidocaine3.6%,Menthol1.25%
Daily patch Q12 followed by Q12 of no patch
Drug: lidocaine 5% patch
10cmx 14 cm transdermal patch sealed in its own pouch
Other Name: Lidoderm

Drug: lidocaine 3.6%, menthol 1.25%
10cmx 14 cm transdermal patch sealed in its own pouch
Other Name: LidoPatch

Placebo Comparator: Lidocaine 3.6%, menthol 1.25% v placebo
Daily patch Q12 followed by Q12 of no patch
Drug: lidocaine 3.6%, menthol 1.25%
10cmx 14 cm transdermal patch sealed in its own pouch
Other Name: 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Quality of life comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale [ Time Frame: Day ten ]
    Statistical superiority sought for lidocaine 3.6%,menthol 1.25% compared to placebo. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten.

  2. Efficacy comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale [ Time Frame: Day 10 ]
    Statistical superiority sought for lidocaine 3.6%,menthol 1.25% compared to placebo. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten.

  3. Side effect comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale [ Time Frame: Day 10 ]
    Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten.

  4. Side effect comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale [ Time Frame: Day 10 ]
    Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749123


Contacts
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Contact: James J Ciullo, MBA 6302512873 jay@lidopatch.com
Contact: Eric Castro, MD 773-771-4160 jedc269@yahoo.com

Locations
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United States, Illinois
Advocate Good Sheppard Hospital Recruiting
Barrington, Illinois, United States, 60010
Contact: Eric Castro, MD    773-771-4160    jedc269@yahoo.com   
Sponsors and Collaborators
J.A.R. Laboratories

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: Study Protocol
Please contact jay@lidopatch.com is study protocol is needed. It will be more direct than going through the website.

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Responsible Party: J.A.R. Laboratories
ClinicalTrials.gov Identifier: NCT02749123     History of Changes
Other Study ID Numbers: 527-03
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Investigators plan to share the study results as a whole but no plans to share individual results.

Additional relevant MeSH terms:
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Arthritis
Back Pain
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Menthol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents